Medical Device made Easy Podcast

Master UDI-DI: The New Layer Many MedTech Companies Don’t Understand

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 30 Apr 2026 00:00:00 +0000

The implementation of Unique Device Identification (UDI) has already transformed regulatory compliance in the medical device industry.

Now, Europe is introducing an additional layer: Master UDI-DI — adding both structure and complexity to the system.

Understanding the UDI Structure

To fully understand Master UDI-DI, it’s important to distinguish between the different levels:

• UDI-DI → Identifies a specific device
• Basic UDI-DI → Groups devices with the same intended purpose and characteristics
• Master UDI-DI → Applies to highly individualized devices with specific design parameters

This new layer aims to better manage products with high variability.

Why Master UDI-DI Was Introduced

For certain devices — such as spectacle frames, lenses, and other customizable products — the number of variations can become overwhelming.

Master UDI-DI helps:
• Reduce the number of identifiers required
• Improve traceability
• Simplify product grouping
• Enhance recall efficiency

Key Benefits

Despite its complexity, Master UDI-DI brings several advantages:

Better organization of device data
Improved market surveillance
Faster identification during recalls
Stronger protection against counterfeit products

Challenges for Manufacturers

However, the implementation is not without challenges:

• Increased data requirements
• Risk of incorrect UDI assignment
• Need for cross-functional coordination
• Integration with EUDAMED

As highlighted in the discussion, errors in UDI can be costly — including recalls and data inconsistencies.

Timeline and Urgency

While the labeling deadline is set for November 2028, manufacturers should not wait.

EUDAMED requirements are already active, and preparation takes time.

Early implementation reduces risk, cost, and operational pressure.

Best Practices

To ensure compliance, manufacturers should:

• Study MDCG guidance documents
• Validate data before submission
• Use tools for UDI calculation
• Involve project managers and cross-functional teams
• Seek expert support when needed

Who is Al Hajj Sam Mostafa?

Al Hajj Sam Mostafa is founder and CEO of UDI Experts. He has nearly 10 years of UDI experience, in which he leads and provides his premiere UDI solutions to MedTech organizations. One of his prestige clients is of the Magnificent Seven (Big Tech) companies. UDI Experts continuously strives to offer their clients the best UDI services for the best prices. Their global services include medical device data collection, data registration, UDI label creation and UDI label support, UDI printing IQ/OQ/PQ, and much more.

Who is Monir El Azzouzi?

Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com

If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.

Link

Website: www.udiexperts.com
Business LinkedIn: www.linkedin.com/in/udi-experts-600138189
Personal LinkedIn: www.linkedin.com/in/al-hajj-sam-m-03b69612
YouTube UDI Video for Dawa Medical (below)
Import IQ: Episode 5 Understanding the UDI with Hussam Mustafa
UDI Experts YouTube Channel: www.youtube.com/@UDIExperts-o3z

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Master UDI-DI: The New Layer Many MedTech Companies Don’t Understand appeared first on Medical Device made Easy Podcast. hamza benafqir

Life After CE Marking: Why AI Medical Devices Need Continuous Monitoring

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Wed, 22 Apr 2026 23:11:05 +0000

Achieving CE marking under the EU MDR is a major milestone for medical device manufacturers. However, for AI-based medical devices, certification is not the end of the journey — it is only the beginning.

In this episode, Osman El-Koubani shares insights into the post-market realities of AI as a Medical Device (SaMD) and what manufacturers must do to remain compliant over time.

CE Certification Is Not the Finish Line

Many companies assume that once their device is certified, the main regulatory burden is over.

In reality, Post-Market Surveillance (PMS) becomes critical — especially for AI systems that can evolve or degrade in real-world conditions.

Relaxing after certification can lead to:
• Loss of control over performance
• Undetected risks
• Regulatory non-compliance

AI in the Real World: Performance Drift

AI models often behave differently once exposed to real-world data. This phenomenon, known as performance drift, can reduce accuracy and reliability over time.

Manufacturers must implement continuous monitoring strategies, including:
• Real-world data (RWD) collection
• Performance tracking
• Feedback loops for improvement

Updating AI Devices: What Is Allowed?

Updating AI systems introduces regulatory complexity.

Key questions include:
• What qualifies as a significant change?
• Does retraining require re-certification?
• How should updates be documented and justified?

Manufacturers often struggle with these decisions, leading to compliance risks.

PCCP: Enabling Controlled Evolution

The concept of a Predetermined Change Control Plan (PCCP) allows manufacturers to define in advance how an AI system can evolve.

While this concept is gaining traction globally, its implementation in Europe is still evolving and requires careful regulatory consideration.

Building a Mature AI PMS System

A robust post-market system for AI devices should include:
• Continuous performance monitoring
• Risk management integration
• Clear documentation of updates
• Strong governance of data and models

Who is Osman El-Koubani

Dr Osman El-Koubani is a doctor and clinical researcher. With nearly a decade of experience at the intersection of healthcare, digital innovation, and AI, he has developed and implemented NHS digital solutions and advised multiple software and AI medical device startups. At Scarlet, Osman works as a Clinical Engineer and AI/ML expert, leading clinical evaluation, risk management, and usability for AI-driven medical devices, while also helping SaMD and AIaMD manufacturers navigate certification and maintain compliance through transparent, practical, and safety-focused regulatory processes.

Who is Monir El Azzouzi?

If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.

Link

Scarlet Linkedin: https://www.linkedin.com/company/scarlet-comply/posts/?feedView=all&viewAsMember=true
Osman Linkedin: https://www.linkedin.com/in/osman-kan/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Life After CE Marking: Why AI Medical Devices Need Continuous Monitoring appeared first on Medical Device made Easy Podcast. hamza benafqir

The Fake QMS Problem: Why Your ISO 13485 System Will Fail an Audit

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 16 Apr 2026 04:32:17 +0000

Many medical device companies believe they have a compliant Quality Management System (QMS).

On paper, everything looks perfect:
• Procedures are written
• Forms are available
• Risk management is documented
• CAPA systems are defined

But during an audit, everything falls apart.

What Is a “Fake QMS”?

A fake QMS is not necessarily incorrect — it is simply not implemented in reality.

Employees may not understand it.
Processes may not be followed.
Evidence may not exist.

In short:
The system exists… but it is not alive.

Why This Happens

There are three common causes:

1. Copy-Paste Systems

Companies reuse QMS from other organizations without adapting them to their own operations.

2. Template-Based QMS

Generic ISO 13485 packages provide documentation — but no real implementation.

3. Consultant-Driven Systems

Consultants build the QMS, but knowledge is never transferred internally.

When they leave, the system collapses.

What Happens During an Audit

Auditors don’t just review documents — they test your system.

Examples include:

• CAPA: Can you explain root cause analysis?
• Risk Management: Do you link PMS data to risk updates?
• Training: Do employees understand their responsibilities?

If the answer is no, nonconformities follow.

The Core Problem

A QMS is not documentation.

It is a living system based on real processes and evidence.

How to Build a Real QMS

To avoid this trap, companies should:

• Build processes based on real operations
• Keep procedures simple and usable
• Define clear responsibilities
• Train employees effectively
• Create traceable evidence
• Use an eQMS for control and integration
• Test the system internally before audits

Final Takeaway

A fake QMS is not just a compliance issue — it is a business risk.

It can lead to:
• Audit failures
• Delays in certification
• Loss of credibility

ISO 13485 is not about having documents.
It’s about proving that your system works.

Who is Monir El Azzouzi?

If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post The Fake QMS Problem: Why Your ISO 13485 System Will Fail an Audit appeared first on Medical Device made Easy Podcast. hamza benafqir

AI Medical Devices: What Notified Bodies Really Look For

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Wed, 08 Apr 2026 11:40:00 +0000

Artificial Intelligence is rapidly transforming the medical device industry, enabling smarter diagnostics, predictive analytics, and personalized healthcare solutions. However, with this innovation comes increased regulatory complexity.

In this episode, Camille Petri shares insights into how Notified Bodies assess AI-based medical devices and what manufacturers need to prepare for successful certification.

Are AI Devices More Difficult to Certify?

Compared to traditional software, AI-based medical devices introduce additional layers of complexity. These include data dependency, algorithm behavior, and potential variability in performance.

Notified Bodies are therefore placing greater emphasis on transparency, traceability, and robustness.

Data: The Foundation of AI Certification

One of the most critical elements in AI certification is the quality of data.

Manufacturers must clearly document:
• Training datasets
• Validation datasets
• Test datasets

Common deficiencies include poor dataset representativeness, lack of traceability, and insufficient justification of data selection.

Clinical Evaluation for AI

Clinical evaluation for AI devices differs from traditional approaches.

Regulators may accept retrospective data in some cases, but increasingly expect strong clinical evidence demonstrating real-world performance.

The challenge lies in proving that the AI system performs consistently across different populations and use cases.

Risk Management in AI

AI introduces new types of risks, including:
• Algorithm bias
• Performance drift over time
• Lack of explainability

Manufacturers must integrate these risks into their risk management process, in line with ISO 14971.

Performance, Validation & Continuous Learning

A key question for regulators is how to manage AI systems that evolve over time.

Notified Bodies often differentiate between:
• Locked algorithms (fixed behavior)
• Continuous learning systems (adaptive models)

Each approach has different regulatory implications, particularly regarding validation and post-market monitoring.

Key Takeaway

AI in MedTech offers tremendous opportunities, but certification requires a strong foundation in data, clinical evidence, and risk management.

Understanding what Notified Bodies expect early in development can significantly improve your chances of a successful submission.

Who is Monir El Azzouzi?

If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.

Link

Camille Petri Linkedin: https://www.linkedin.com/in/camillepetri/
Scarlet Linkedin: https://www.linkedin.com/company/scarlet-comply/posts/?feedView=all&viewAsMember=true

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post AI Medical Devices: What Notified Bodies Really Look For appeared first on Medical Device made Easy Podcast. hamza benafqir

Medical Device News APRIL 2026 Regulatory Update

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Wed, 01 Apr 2026 23:41:22 +0000

Medboard

Sponsor: Medboard: https://www.medboard.com/

Extension of WET Class Iib – A new list with new products mentioned: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=PI_COM:C(2026)1809
Update your MIR form – Version 7.3.1: https://health.ec.europa.eu/document/download/e8ce9f53-82cb-44c8-a06e-91ad71c16b01_en?filename=md_new-reg_mir-form-v7.3.1_en.pdf

Future Regulation -Implementation: https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices/implementation-of-the-future-regulations
- Consultation on indefinite recognition of CE marked medical devices and current transitional arrangements
- Pre-market Statutory Instrument (SI)
- Future Enhancemens: Exceptional Use Authorization and Health Institution exemption
- Post-market Surveillance Requirements
- Update to guidances

Learn Clinical Investigation in the UK – Lot of questions answered:
- Clinical investigations for electrically powered devices : https://www.gov.uk/government/publications/clinical-investigations-for-electrically-powered-devices/clinical-investigations-for-electrically-powered-devices
- Clinical investigations: investigators’ responsibilities : https://www.gov.uk/government/publications/clinical-investigations-investigators-responsibilities/guidance-for-clincal-investigators
- Clinical investigations: statistical considerations : https://www.gov.uk/government/publications/clinical-investigations-statistical-considerations/statistical-considerations
- Medical devices that need a clinical investigation: https://www.gov.uk/government/publications/medical-devices-that-need-a-clinical-investigation
- Determining if Clinical Investigation is required: https://www.gov.uk/government/publications/medical-devices-that-need-a-clinical-investigation/determining-if-a-clinical-investigations-is-required
- Clinical Investigation Flow chart: https://assets.publishing.service.gov.uk/media/696f850b5b6060ca6736a0ae/flow_chart_for_clinical_investigations_v3.png

Events

Team NB: Training IVDR -July 2nd 2026: https://www.team-nb.org/wp-content/uploads/2026/03/Leaflet-IVD-TD-Manufacturers-Training-20260702.pdf
Egypt: Vigilance reporting Training – April 7 to 9, 2026: https://tinyurl.com/emdpodcast
MedtechConf.com – Check the MAP
- EU
  - Swiss Medtech Day 2026 – June 10, 2026: https://medtechconf.com/event/why-swiss-medtech-day-matters-what-you-should-know/
  - Medtech Forum – May 11, 2026: https://medtechconf.com/event/the-medtech-forum-2026-shaping-the-future-of-medical-technology-in-europe/
- US
  - Veeva Medtech US Summit- May 11. 2026: https://medtechconf.com/event/veeva-medtech-us-summit-2026-innovation-data-modernization-in-medical-devices/
- Brazil
  - Hospitalar – May 19,2026: https://medtechconf.com/event/hospitalar-the-reference-event-for-healthcare-innovation-and-solutions-in-latin-america/

RoW

Australia: Software Advertisment -What to say: https://www.tga.gov.au/resources/guidance/advertising-software-based-medical-devices-australia

Your advertisement must contain:

an accurate description of the device
the trade name of the device
the intended purpose(s) of the device
any mandatory statements and, where relevant, health warnings.

For example, you must not:

claim your product is “TGA approved”
make unsubstantiated claims about the product’s performance
include endorsements or testimonials from health professionals or medical researchers.
Malaysia: Guidance Creation/Update – Medical Device Act 2012
- Guidance on Definition of Medical Devices: https://portal.mda.gov.my/index.php/announcement/1777-publication-of-second-edition-of-guidance-document-on-definition-of-medical-devices
- Guidance on confirmation of obsolete and discontinued medical device: https://portal.mda.gov.my/index.php/announcement/1778-publication-of-first-edition-of-guidance-document-on-application-for-confirmation-status-of-obsolete-and-discontinued-medical-devices
- Guidance on import and/or supply of unregistered medical devices under special access exemption application: https://portal.mda.gov.my/index.php/announcement/1779-publication-of-third-edition-of-guidance-document-on-import-and-or-supply-of-unregistered-medical-devices-under-special-access-exemption-application
India: FAQ on IVD products – 24 questions with answers: https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/Addendum-Doc-No-CDSCOIVDFAQ-042022dated-13032026.pdf
Egypt: What you need to register – List of documents: https://tinyurl.com/EmdEgyptRegistration

Podcast

Podcast Nostalgia -Let’s remember: https://podcast.easymedicaldevice.com/
- Episode 381: EUDAMED deadline 2026: https://podcast.easymedicaldevice.com/381-2/
- Episode 382: Best-of of 3 podcasts: https://podcast.easymedicaldevice.com/382-2/

Service

New Website: https://easymedicaldevice.com
- Authorized Representative
- Consulting
- Training
EasyIFU: https://easyifu.com
Smarteye: https://eqms-smarteye.com/

The post Medical Device News APRIL 2026 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

These 3 podcasts will change how you see MedTech

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 26 Mar 2026 01:10:24 +0000

The medical device industry is evolving rapidly, driven by stricter regulations, innovation, and global market challenges.
To help you stay ahead, we’ve gathered the most valuable insights from three MedTech podcasts into one concise summary.

In this article/video, we explore:

Key regulatory challenges related to FDA and MDR
Common mistakes that delay device approval
Strategic advice from industry experts

These insights highlight one essential truth: success in MedTech is not only about innovation, but also about understanding regulatory pathways and execution.

Whether you are a startup founder, regulatory professional, or industry enthusiast, these lessons will help

The post These 3 podcasts will change how you see MedTech appeared first on Medical Device made Easy Podcast. hamza benafqir

EUDAMED Deadline 2026 – 7 Steps Every MedTech Company Must Prepare

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 19 Mar 2026 03:18:44 +0000

The upcoming EUDAMED deadline on May 28, 2026, marks a major shift in how regulatory data is managed under the EU MDR and IVDR.

While many companies believe this transition is simply about uploading documents into a European database, the reality is far more complex.

EUDAMED is not just a database — it is becoming the central regulatory infrastructure of the European medical device ecosystem, connecting manufacturers, notified bodies, regulators, and economic operators.

Why EUDAMED Matters

EUDAMED aims to increase:
• Transparency
• Traceability
• Post-market surveillance
• Regulatory oversight

To achieve this, companies must ensure that their internal data is structured, accurate, and aligned with regulatory expectations.

The Biggest Mistake

The most common misconception is treating EUDAMED as an IT project.

In reality, it is a data governance challenge.

Before uploading any device, companies must clearly define:
• Device families
• Basic UDI-DI and UDI-DI
• Certificate linkage
• Legal manufacturer responsibilities

Many organizations struggle with these fundamentals.

The 7-Step Readiness Checklist

To prepare effectively, QA/RA teams should focus on:

Actor registration (SRN)
Cleaning the device portfolio
Validating the UDI structure
Checking certificate data
Defining legacy device strategy
Assigning data ownership
Performing a dry run

Risks of Delayed Preparation

Companies that delay preparation may face:
• Incomplete or inconsistent data
• Registration delays
• Regulatory bottlenecks
• Internal confusion

EUDAMED could quickly become a regulatory traffic jam for unprepared organizations.

A Practical Timeline

To avoid these risks:

• Immediately: Audit all regulatory data
• Next 1–2 months: Validate UDI structure and device hierarchy
• Before the deadline: Perform a full readiness simulation

Final Takeaway

EUDAMED is not just a compliance requirement — it is a transformation of how regulatory information is managed in Europe.

Companies that prepare early will transition smoothly.
Those that wait may face significant delays and operational challenges.

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post EUDAMED Deadline 2026 – 7 Steps Every MedTech Company Must Prepare appeared first on Medical Device made Easy Podcast. hamza benafqir

Medical Device News March 2026 Regulatory Update

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Fri, 13 Mar 2026 02:05:23 +0000

Medboard

Sponsor: Medboard: https://www.medboard.com/

Europe

Pharmacist are distributors – French guide issued to educate them: https://medboard-public-assets.s3.amazonaws.com/Regulatory/9b892d08-611c-4326-a40e-750e0364df27.pdf

Team NB

Team NB position Paper – Reduced Scrutiny, Cost saving: https://www.team-nb.org/wp-content/uploads/2026/03/Team-NB-PositionPaper-MDR-IVDR-revision-impact-on-the-sector-20260302.pdf
Team-NB Demonstrate Safety and performance – For Combination of reagent and other equipment: https://www.team-nb.org/wp-content/uploads/2026/02/Team-NB-PositionPaper-Demonstration-of-Safety-and-Performance-for-Combinatorial-Use-of-Devices-or-Equipment-V1-20260216.pdf
Team-NB- Letter on Cybersecurity – New Proposal again: https://www.team-nb.org/wp-content/uploads/2026/02/Team-NB-Letter-on-cybersecurity-20260205.pdf
Team-NB – MDR Clinical & Tech File Training – Check the dates: https://medboard-public-assets.s3.amazonaws.com/Regulatory/442102-Leaflet-MDR-Clinical-Manufacturers-Training-20260528.pdf and https://www.team-nb.org/wp-content/uploads/2026/02/Leaflet-MDR-TD-Manufacturers-Training-20260429.pdf

Consultation on recognizing CE mark – Should it be indefinitely: https://www.gov.uk/government/consultations/medical-devices-regulations-targeted-consultation-on-the-indefinite-recognition-of-ce-marked-devices
- Consultation until: April 10, 2026
UK Reliance is ongoing – Draft proposal to recognize MDSAP and other: https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices/statement-of-policy-intent-international-recognition-of-medical-devices
Bookmark the MHRA contact page -*Whispering* If you want to Whistleblow, there is a contact Chuuut!!!: https://www.gov.uk/guidance/contact-mhra

Solutions

EasyIFU: For eifu and Label – Test it for Free: https://easyifu.com
Smarteye: for eQMS . Ask for a Demo: https://eqms-smarteye.com/

RoW

IMDRF
- Reliance Playbook – With examples to apply: https://www.imdrf.org/sites/default/files/2026-02/IMDRF%20GRRP%20WG%20N89%20Reliance%20Playbook.pdf
USA
- FDA Cybersecurity documentation – Final Guidance: https://www.fda.gov/media/119933/download
Malaysia
- Launch of the Innovative Pathway – Accelerate the development of your device: https://portal.mda.gov.my/index.php/announcement/1771-implementation-of-the-innovative-medical-device-review-pathway-by-medical-device-authority-ministry-of-health-malaysia
Argentina
- Self Declaration expended for Low-Risk devices – Themis platform to be used: https://www.argentina.gob.ar/noticias/entra-en-vigencia-el-nuevo-regimen-simplificado-para-la-habilitacion-de-establecimientos

Podcast

Episode 376 – Defect Management in SaMD with Anindya Mookerjea: https://podcast.easymedicaldevice.com/376-2/
Episode 377 – IEC 60601 4th edition with Leo Eisner: https://podcast.easymedicaldevice.com/377-2/
Episode 378 – IMDRF & Regulatory Reliance with Stephanie Grassmann: https://podcast.easymedicaldevice.com/378-2/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Medical Device News March 2026 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

IMDRF & Regulatory Reliance Explained: The Future of Global Medical Device Approvals

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 05 Mar 2026 01:06:22 +0000

The global medical device regulatory environment is complex, often requiring manufacturers to repeat similar submissions and audits across multiple countries. This duplication slows innovation and delays patient access to life-saving technologies.

To address this challenge, international regulators are increasingly collaborating through the International Medical Device Regulators Forum (IMDRF).

In this podcast episode, Stephanie Grassmann (MedTechXperts) joins us to discuss how the concept of Regulatory Reliance is transforming global medical device approvals.

What is IMDRF?

The International Medical Device Regulators Forum (IMDRF) is a voluntary group of regulatory authorities working together to harmonize medical device regulations and reduce duplication across global markets.

Members include major regulatory bodies such as:

• United States (FDA)
• European Union
• Australia (TGA)
• Brazil (ANVISA)
• Canada (Health Canada)
• China (NMPA)

Their mission is to promote efficient regulation while maintaining high standards of safety and performance.

Understanding Regulatory Reliance

Regulatory reliance allows one authority to give significant weight to the work already performed by another trusted regulator.

Instead of repeating full assessments, authorities can leverage existing evaluations, reducing regulatory burden while maintaining confidence in safety and effectiveness.

Real-World Success Stories

Several regulators are already demonstrating the benefits of reliance mechanisms.

Australia – TGA

A Class III Mitral Valve Clip reached market access in just 20 working days after the regulator accepted evidence generated overseas.

Argentina – ANMAT

Dental instruments known as endodontic barbed broaches were approved in 9 working days using reliance pathways.

Brazil – ANVISA

Companies holding MDSAP certification may skip immediate on-site audits, saving both time and money during market entry.

These examples show how regulatory cooperation can significantly accelerate approvals.

The Role of MDSAP

The Medical Device Single Audit Program (MDSAP) allows manufacturers to undergo a single regulatory audit recognized by multiple countries.

This program plays a key role in enabling reliance between regulatory authorities and reducing redundant inspections.

The European Perspective

Europe has historically maintained a distinct regulatory framework under EU MDR and IVDR.

However, recent proposals—including references to Articles 108a and 108b—suggest increasing collaboration with international frameworks such as IMDRF and MDSAP.

While a single global approval system remains a long-term goal, reliance initiatives are already demonstrating that cooperation between regulators can improve efficiency without compromising safety.

Looking Ahead

For manufacturers and startups, embracing international regulatory frameworks early—such as MDSAP and IMDRF guidance—can significantly improve global market access strategies.

As regulatory collaboration grows, the future of medical device approvals may become faster, more harmonized, and more patient-centered.

Who is Monir El Azzouzi?

If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.

Link

Stephanie Grassmann Linkedin: https://www.linkedin.com/in/stephaniegrassmann-medtechxperts/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post IMDRF & Regulatory Reliance Explained: The Future of Global Medical Device Approvals appeared first on Medical Device made Easy Podcast. hamza benafqir

IEC 60601 – From 2nd to 4th Edition: What Manufacturers Must Know

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 26 Feb 2026 00:00:00 +0000

IEC 60601 has been central to medical electrical equipment safety for decades. From the prescriptive approach of the 2nd edition to the risk-based philosophy introduced in the 3rd edition, the standard has continuously evolved to address technological and regulatory complexity.

Now, the upcoming 4th edition represents more than an amendment — it signals a structural transformation.

This article explores:

The Evolution of IEC 60601

• Key shifts from the 2nd to the 3rd edition
• Why risk management became central
• What lessons shaped today’s safety philosophy

What the 4th Edition Brings

• A major rewrite rather than incremental updates
• The introduction of “atomic requirements”
• Structural clarity for manufacturers, test labs, and regulators
• Emerging technical considerations (digitalization, AI, cybersecurity, home use)

Impact on Existing Devices

• Will re-testing be required?
• How to assess validity of existing test reports
• Transition strategies with notified bodies

Integration into Design & Documentation

• Embedding IEC 60601 into risk management from day one
• Required updates in risk files, EMC documentation, labeling, and usability engineering
• Practical advice for SMEs with limited resources

The Future of IEC 60601

• Greater harmonization with ISO 14971 and IEC 62304
• Alignment with digital and AI regulatory frameworks
• The long-term outlook for medical electrical safety

For manufacturers, the message is clear:
IEC 60601 is not just a testing standard — it is a design and risk management framework that must be integrated early and strategically.

Who is Monir El Azzouzi?

If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.

Link

Leo Linkedin: https://www.linkedin.com/in/leoeisnersafetyconsultants/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post IEC 60601 – From 2nd to 4th Edition: What Manufacturers Must Know appeared first on Medical Device made Easy Podcast. hamza benafqir

Defect Management in SaMD — From Chaos to Control

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 19 Feb 2026 00:00:00 +0000

In Software as a Medical Device (SaMD), defect management is far more than tracking bugs. It is a structured, risk-driven process that directly impacts patient safety, regulatory compliance, and product lifecycle control.

This article (and podcast episode) explores both foundational and advanced perspectives on defect management in regulated software environments.

We cover:

Understanding Defects in SaMD

• What defines a defect in a regulated context
• How defect management differs from non-medical software
• The relationship between defects, risk management, and ISO 14971

Building a Compliant Defect Management Process

• Essential documentation and tools
• Severity and priority categorization
• Handling defects discovered during validation or post-market
• Differentiating between defects, change requests, and requirement gaps

Advanced & Real-World Scenarios

• Managing safety-critical defects
• When CAPA or vigilance reporting is required
• Handling SOUP and third-party component issues
• Ensuring traceability across versions and product variants
• Agile defect management strategies

Audit Perspective & Common Pitfalls

• Frequent gaps identified by regulators and notified bodies
• How defect trend data supports CAPA and management review
• Practical advice for startups implementing lightweight but compliant systems

We also discuss how modern eQMS platforms (such as SmartEye) can help streamline documentation, automate traceability, and improve oversight without adding unnecessary bureaucracy.

Defect management in SaMD is not about documentation — it’s about maintaining control over risk and ensuring safe, effective software throughout its lifecycle.

Who is Monir El Azzouzi?

If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.

Link

Anindya Mookerjea Linkedin: https://www.linkedin.com/in/anindyamookerjea/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Defect Management in SaMD — From Chaos to Control appeared first on Medical Device made Easy Podcast. hamza benafqir

Medical Device News February 2026 Regulatory Update

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Wed, 11 Feb 2026 22:37:44 +0000

SPONSOR

Medboard: https://www.medboard.com/

EUROPE

New Harmonization Standards – Implementing Decision 2026/193:

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202600193
- Neurosurgical implants
- EN ISO 14155:2020 on clinical investigations
- EN ISO 18562 series on Biocompatibility for Breathing gas pathways

Germany: Transition from DMIDS to EUDAMED – March 19, 2026:
- https://www.bfarm.de/DE/Aktuelles/Veranstaltungen/Termine/2026-03-19-registrierung-mp.html?nn=986770
  - EUDAMED mandatory by May 28th, 2026

High-Level Conference on Medical Devices – March 16th, 2026 – Brussels:
- https://health.ec.europa.eu/events/high-level-conference-medical-devices-innovation-and-patient-safety-16-march-2026-brussels-belgium-2026-03-16_en

The conference will feature three breakout sessions focusing on:

Enhanced predictability for conformity assessments: combining certainty with flexibility
Clinical evidence at EU level to support the regulatory framework: the key role of Expert Panels
Breakthrough technologies for better care: turning guidance into reality

Team-NB: Letter on Cybersecurity – MDR and IVDR proposal draft version:
- https://www.team-nb.org/wp-content/uploads/2026/02/Team-NB-Letter-on-cybersecurity-20260205.pdf

Switzerland

Swissmedic inspection on Importers -30 importers, 232 product samples, RESULT?:
- https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/infos/smc-ueberprueft-ch-importeure-2025.pdf.download.pdf/md-schwerpunktaktion-importeure-2025_en.pdf
Swissdamed Webinar – May 28th, 2026:
- https://www.swissmedic.ch/swissmedic/en/home/services/veranstaltungen/swissdamed-webinar.html

UK to exempt Health Institution – Not a priority for now
- https://www.gov.uk/government/publications/health-institution-exemption-for-general-medical-devices

Training

Team-NB: Training on MDR technical Documentation – For manufacturers on April 19th, 2026:
- https://www.team-nb.org/new-session-mdr-technical-documentation-training-for-manufacturers/

EasyIFU

Create eIFU and Labels easily – Compliance to EU MDR/IVDR:
- Https://easyifu.com

RoW

North America

FDA: General Wellness devices – Guidance by the FDA:
- https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-wellness-policy-low-risk-devices
FDA: Cybersecurity in Medical Devices – QMS and Pre-market submission:
- https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-medical-devices-quality-management-system-considerations-and-content-premarket

APAC

Malaysia: Electronic Certificates issued by MDA – For FSC, Manufacturing Certificates and Export Certificates
- https://portal.mda.gov.my/index.php/announcement/1746-implementation-of-electronic-certificates-for-certificate-of-free-sale-manufacturing-certificate-and-export-certificate-issued-by-medical-device-authority-mda-malaysia
India: Import of IVD – Online Portal: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTM4NDE%3D

Africa:

Egypt: Database for Product Registration -Online Electronic Service:

https://eservicesdata.edaegypt.gov.eg/MedicalDevices

Middle East

Saudi Arabia: SFDA inspection of QMS requirements – Process that would be followed:
- https://www.sfda.gov.sa/sites/default/files/2026-01/MDS-REQ10E.pdf

Podcast

Episode 372 – How to remediate a Design History File (DHF): https://podcast.easymedicaldevice.com/372-2/
Episode 373 – QMSR is coming: Why FDA inspections with change completely in 2026: https://podcast.easymedicaldevice.com/373-2/
Episode 374 – Validation & Supplier Management in MedTech: https://podcast.easymedicaldevice.com/374-2/

Services

Consulting support: info@easymedicaldevice.com
Authorized Representative: EO@easymedicaldevice.com

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Medical Device News February 2026 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

Validation & Supplier Management in MedTech

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 05 Feb 2026 00:00:00 +0000

Validation is a cornerstone of medical device compliance — yet it remains one of the most challenging areas for manufacturers. In this podcast episode, Simon Foeger, Founder of SIFO MEDICAL, shares real-world experience and practical guidance on validation, risk management, and supplier development.

Key topics discussed include:

Test Method Validation: definition, regulatory expectations, and when it is required
FDA warning letters and the risks of non-compliant validation approaches
Common pitfalls and best practices for Test Method Validation
Process Validation and Packaging Validation
The role of statistics in MedTech, including sample size justification
Risk management linked to validation activities
Supplier management, from sourcing components to audits and long-term supplier development

Simon also explains how SIFO MEDICAL supports medical device manufacturers through consulting and online training focused on:

Process validation and equipment qualification
Test Method Validation training
ISO 13485 and 21 CFR 820.30 compliance
Supply chain development, including injection molding and cleanroom manufacturing environments

This episode is essential for quality managers, regulatory professionals, validation engineers, and MedTech manufacturers looking to strengthen compliance, avoid warning letters, and build robust validation strategies.

Who is Monir El Azzouzi?

If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.

Link

Simon Foeger Linkedin: https://www.linkedin.com/in/simonfoeger/
Sifo-medical: https://www.sifo-medical.com

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Validation & Supplier Management in MedTech appeared first on Medical Device made Easy Podcast. hamza benafqir

QMSR Is Coming: Why FDA Inspections Will Change Completely in 2026

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Wed, 28 Jan 2026 22:31:53 +0000

For decades, medical device manufacturers in the US relied on 21 CFR 820 (QSR) — a system known for being procedural and checklist-oriented.
But starting February 2nd, 2026, FDA will implement QMSR, changing not only the regulation structure but also the inspection philosophy.

QMSR does not eliminate Part 820. Instead, FDA is amending it to incorporate ISO 13485:2016 by reference, bringing the US closer to the global quality language used across Europe, Canada, Japan, and beyond.

Why FDA is doing this

FDA’s move is driven by three key goals:

Harmonization (reduce duplicated systems and audits)
Modern quality thinking (move from “procedures” to “system effectiveness and risk”)
Inspection efficiency (more end-to-end audits)

What inspections may look like under QMSR

Instead of jumping between SOPs, inspections may follow real flows like:
Complaint → Risk Management → CAPA → Design Change → Supplier Impact
The focus becomes traceability, consistency, and risk-based justification.

What companies should do now

To be QMSR-ready, companies should:

Build an ISO 13485-style process map
Make risk visible everywhere, not only in product development
Improve CAPA triage and effectiveness checks
Strengthen design controls (especially software development & V&V)
Train teams on the new “why/how” inspection style

Who is Monir El Azzouzi?

If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com

If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post QMSR Is Coming: Why FDA Inspections Will Change Completely in 2026 appeared first on Medical Device made Easy Podcast. hamza benafqir

How to Remediate a Design History File (DHF)

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 22 Jan 2026 00:00:00 +0000

Design History File (DHF) remediation is rarely planned — yet it is a recurring challenge for many medical device manufacturers, especially during audits, inspections, acquisitions, or regulatory framework changes.

In this podcast episode, we provide a structured and practical discussion on:

The definition and purpose of a DHF
Key differences between FDA QMSR and ISO 13485 requirements
How the DHF concept is addressed within ISO 13485
When DHF remediation becomes unavoidable
Typical causes of remediation, including accumulated DHF debt
How to remediate a DHF without creating new compliance risks
Common pitfalls and practices to avoid
How to define a realistic and defensible remediation strategy
Regulatory communication considerations with:
- National Competent Authorities
- Notified Bodies

This episode is based on an article developed by Wega Informatik AG and is intended to help MedTech professionals approach DHF remediation in a controlled, transparent, and compliant way.

If you are responsible for design controls, quality systems, or regulatory compliance, this episode will help you avoid costly mistakes and build confidence in your remediation approach.

Links

Richie Christian Linkedin: https://www.linkedin.com/in/christianrichie/
https://www.wega-it.com/remediation-of-medical-device-design-history-file/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post How to Remediate a Design History File (DHF) appeared first on Medical Device made Easy Podcast. hamza benafqir

Medical Device News January 2026 Regulatory Update

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 15 Jan 2026 01:23:46 +0000

Medboard: https://www.medboard.com/
Europe
- EMD Mag Issue 3 – For QA RA people: https://easymedicaldevice.com/emd-mag/
- EU to simplify MDR and IVDR – Proposal ongoing: https://health.ec.europa.eu/document/download/25e7ea7c-cab3-40cf-86d9-d11f5e7744d8_en?filename=md_com_2025-1023_act_en.pdf – https://ec.europa.eu/commission/presscorner/api/files/document/print/en/qanda_25_3078/QANDA_25_3078_EN.pdf – https://ec.europa.eu/commission/presscorner/api/files/attachment/882087/FACTSHEET%20medical%20devices%20final%20(1).pdf
- Team NB Position Paper on Annex VII – Not agreeing all EU Proposal: https://www.team-nb.org/wp-content/uploads/2025/12/Team-NB-PositionPaper-Annex-VII-V1-20251216.pdf
- MDCG 2025-9 Learn Breakthrough Devices BtX – Guidance for innovative products: https://health.ec.europa.eu/document/download/edca94c7-62ab-4dd5-8539-2b347bd14809_en?filename=mdcg_2025-9.pdf
  - Infographic: https://www.linkedin.com/posts/melazzouzi_medtech-mdr-ivdr-activity-7414590943179202560-jbxH?utm_source=share&utm_medium=member_desktop&rcm=ACoAAABZ07ABDocaBMTLJo8bsl8V3bgNSBIiZuI
- MDCG 2025-10 on PMS – Learn how to do it with this guidance: https://health.ec.europa.eu/document/download/a9ad86b7-1b8e-4bae-beb4-48b2b3ed2f05_en?filename=mdcg_2025-10_en.pdf
- Notified Body Malta Conformity Assessment – 52nd Notified Body for MDR: https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/notifications?organizationRefeCd=SIMS_INPUT_282916&filter=notificationStatusId:1

Services
- EasyIFU – Manage your eIFU and Labels: https://easyifu.com

Switzerland
- Swissdamed registration deadline – July 1st 2026: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank/swissdamed-informationen/frist-produktregistrierung-in-swissdamed.html – https://swissdamed-webinar.ch/#E402A0
UK
- MHRA Price changing -: More cost for manufacturers: https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market#fees

RoW
- FDA: How to use Real World Evidence – Guidance Document offered: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-real-world-evidence-support-regulatory-decision-making-medical-devices
- Australia: Preparing for UDI and AusUDID – Checklist for preparation available: https://www.tga.gov.au/sites/default/files/2025-12/preparing-for-udi-in-australia-checklist_0.pdf

Podcast
- Podcast Nostalgia – What was discussed lastly:
  - Episode 367 – From Engineer to Clinical Evaluation Expert – Florian Tolkmitt: https://podcast.easymedicaldevice.com/367-2/
  - Episode 368 – Simplifying EU MDR IVDR with Adam Isaacs Rae: https://podcast.easymedicaldevice.com/368-2/
  - Episode 369 – Last Podcast of the Year: https://podcast.easymedicaldevice.com/369-2/
  - Episode 370 – Verification & Validation with Aaron Joseph: https://podcast.easymedicaldevice.com/370-2/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Medical Device News January 2026 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

Verification & Validation Explained — A Practical Conversation with Aaron Joseph

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Wed, 07 Jan 2026 23:32:07 +0000

Verification & Validation (V&V) plays a central role in ensuring that medical devices are safe, effective, and compliant — yet it remains one of the most challenging phases for many teams.

In this podcast episode, we sit down with Aaron Joseph, medical device development expert and author of the well-known article “Top 10 V&V Fails”, to explore why V&V so often becomes a source of stress — and how teams can do better.

Throughout the discussion, we cover:

A clear, simple explanation of Verification vs. Validation
Why V&V must span the entire development lifecycle
How poor requirements create downstream V&V failures
The risks of starting V&V planning too late
How to simplify test methods without losing rigor
Practical strategies for handling failed tests
How to think about traceability without fear
The future of V&V as software and AI become more prevalent

This episode is designed to educate, demystify, and inspire QA/RA professionals, engineers, and MedTech leaders looking to build stronger, more resilient development processes.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.

Social Media to follow

Aaron Joseph linkedin: https://www.linkedin.com/in/ajosephprofile/
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Verification & Validation Explained — A Practical Conversation with Aaron Joseph appeared first on Medical Device made Easy Podcast. hamza benafqir

Last Podcast of the Year – Easy Medical Device | Year in Review & What’s Next

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Wed, 31 Dec 2025 23:30:53 +0000

As the year closes, this special podcast episode offers a comprehensive overview of what happened at Easy Medical Device in 2025 and the key priorities shaping 2026.

The episode reflects on a full year of continuous content creation, including:

Weekly podcast episodes covering global medical device regulations
Increased focus on artificial intelligence and its impact on QA/RA roles
Educational initiatives such as EMD Mag, designed to make complex regulatory topics more accessible
Development of digital tools like EasyIFU, labeling automation, and eQMS solutions
Expansion of consulting, back-office services, and international presence

The discussion also addresses upcoming challenges:

Increasing pressure on Notified Bodies
Risks for late MDR/IVDR transitions
The importance of anticipation and regulatory strategy for new and existing manufacturers

More than a recap, this episode is a strategic pause — an opportunity to reflect, learn, and prepare for the years ahead in a rapidly evolving medtech regulatory environment.

Who is Monir El Azzouzi?

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Last Podcast of the Year – Easy Medical Device | Year in Review & What’s Next appeared first on Medical Device made Easy Podcast. hamza benafqir

Simplifying EU Medical Device Regulations: Understanding the 2025 Proposal

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Wed, 24 Dec 2025 23:27:39 +0000

The European medical device sector is a vital pillar of healthcare innovation, employing over 930,000 people and representing a market of approximately €170 billion. However, since the implementation of MDR and IVDR, manufacturers—especially SMEs—have faced increasing regulatory complexity, long certification timelines, and reduced market predictability.

In this podcast episode, we explore the 2025 EU proposal designed to address these challenges by simplifying regulatory processes while preserving patient safety.

The discussion covers:

Key shortcomings of the current MDR/IVDR framework
The impact on innovation, availability of devices, and SMEs
The eight reform pillars, including proportionality, digitalisation, international cooperation, and improved coordination with EMA and Notified Bodies
How upcoming EU legislation (AI Act, Cybersecurity Act, Biotech Act) will interact with medical device regulations

This episode provides practical insights for manufacturers, regulatory professionals, and policymakers seeking to anticipate regulatory changes and adapt their strategies accordingly.

Listen to the full episode to understand how EU medical device regulation may evolve beyond 2025—and what it means for your organization.

Who is Monir El Azzouzi?

Links

Linkedin Adam: https://www.linkedin.com/in/adam-isaacs-rae/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Simplifying EU Medical Device Regulations: Understanding the 2025 Proposal appeared first on Medical Device made Easy Podcast. hamza benafqir

From Engineer to Clinical Evaluation Expert – The Journey of Florian Tolkmitt

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Wed, 17 Dec 2025 22:24:49 +0000

Clinical Evaluation has become one of the most critical — and challenging — domains under the EU MDR. But how does one build real expertise in this field?

In this episode of the Medical Device Made Easy podcast, Monir El Azzouzi interviews Florian Tolkmitt, Clinical Evaluation Expert at Pro-Liance, to explore his journey from engineering into clinical evaluation and regulatory science.

The discussion covers:

Florian’s education and early career path
How he specialized in Clinical Evaluation
Key lessons learned since the implementation of the EU MDR
What Notified Bodies really expect from clinical documentation
Frequent mistakes manufacturers make in clinical submissions
The evolving role of consultants in supporting compliance
How AI and digital tools may transform literature review and evidence generation
Advice for young professionals entering the MedTech field

This episode offers practical insights, career inspiration, and forward-looking perspectives for anyone working — or aspiring to work — in clinical evaluation and regulatory affairs.

Who is Monir El Azzouzi?

Links

Linkedin florian: https://www.linkedin.com/in/florian-tolkmitt-clinical-evaluation/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post From Engineer to Clinical Evaluation Expert – The Journey of Florian Tolkmitt appeared first on Medical Device made Easy Podcast. hamza benafqir

Medical Device News DECEMBER 2025 Regulatory Update

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 11 Dec 2025 00:00:00 +0000

Medboard

Europe

48% disruption in the EU – I hope you are all healthy: https://health.ec.europa.eu/document/download/13b2c812-b144-4489-af1f-e76af5bc97fd_en?filename=md_availability_study_presentation_2024.pdf
Consultation: SCHEER asks you – Are Brain Stimulators for non-medical purpose dangerous: https://health.ec.europa.eu/consultations/scheer-public-consultation-preliminary-scientific-opinion-health-hazards-and-risks-associated-use_en
Q&A Medicines used with Medical Devices – Revision 6 with new questions: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/questions-answers-implementation-medical-devices-vitro-diagnostic-medical-devices-regulations-eu-2017-745-eu-2017-746_en.pdf
EUDAMED is Mandatory – From 28 May 2026: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202502371 – https://health.ec.europa.eu/latest-updates/eudamed-four-first-modules-will-be-mandatory-use-28-may-2026-2025-11-27_en

Better Call MHRA – But we don’t consult: https://www.gov.uk/guidance/medical-devices-get-regulatory-advice-from-the-mhra

Standard

ISO 10993-1 mutation – Nothing is automatic anymore: https://www.youtube.com/watch?v=AkSZVNSz5a0
ISO 18969 draft – Comments until 28-01-2026: https://www.youtube.com/watch?v=zCR9HlHJ5l0

EasyIFU

Create your Labels with EasyIFU – UDI included: https://easyifu.com

Rest of the World

Argentina

Argentina: Simplified application – Class I/A or Class II/B: https://www.argentina.gob.ar/noticias/anmat-establece-un-regimen-simplificado-para-la-habilitacion-de-establecimientos

Canada

Canada: Modernization of the MDEL – Some changes: https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/medical-devices-compliance-bulletin/consultation-modernizing-mdel-framework-phase-ii.html
Canada: Medical Device License Application – Guidance on how to do it: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/managing-applications-licenses.html

Brazil:

Brazil: Digitalisation of Certificates – You can request that online now: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2025/anvisa-lanca-nova-ferramenta-para-emitir-certificados-de-dispositivos-medicos

Podcast

Podcast Nostalgia – Let’s review previous podcasts

Episode 363 – The journey of a CRO with Helene Quie: https://podcast.easymedicaldevice.com/363-2/
Episode 364 – What is changing with the new ISO 10993-1 with Marina Daineko: https://podcast.easymedicaldevice.com/364-2/
Episode 365 – How to become a Lead Auditor with Rob Packard: https://podcast.easymedicaldevice.com/365-2/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Medical Device News DECEMBER 2025 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

How to become a LEAD AUDITOR made Easy

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 04 Dec 2025 00:20:05 +0000

Becoming a Lead Auditor is one of the most valuable career steps for quality and regulatory professionals in the MedTech sector. Lead Auditors play a critical role in evaluating QMS performance, improving compliance, and preparing organizations for ISO certification.

In this podcast episode, we explore:

What is a Lead Auditor?

The responsibilities, authority, and role differences between internal audits, supplier audits, and certification audits.

Who can become a Lead Auditor?

The competencies required, background expectations, and what makes a good auditor.

What you must learn to be effective:

ISO 19011 — the core auditing guideline
ISO 13485 — the medical device QMS standard
ISO 14971 — risk management for medical devices
Software lifecycle & technical documentation considerations

Do Lead Auditor certificates expire?

Clarifying the myth around renewal, competency maintenance, and the expectations of certification bodies.

Spotlight: Lead Auditor Training by Medical Device Academy

We review the upcoming training course, covering:

Curriculum and learning objectives
Exam format
Prerequisites
Pricing
Training dates
Certificate details

Learn more or register here: https://medicaldeviceacademy.com/lead-auditor-training/

This episode is ideal for QA/RA specialists, QMS managers, consultants, and anyone aiming to take a leadership role in medical device auditing.

Who is Monir El Azzouzi?

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post How to become a LEAD AUDITOR made Easy appeared first on Medical Device made Easy Podcast. hamza benafqir

What is changing with the new ISO 10993-1 version 2025

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 27 Nov 2025 00:00:00 +0000

The long-awaited revision of ISO 10993-1 is almost here – and the MedTech community is full of questions.
Will we need to retest everything?
Is this a complete game-changer, or just an evolution?
How will Notified Bodies and the FDA react?

In this episode of the Medical Device Made Easy Podcast, Monir El Azzouzi hosts Marina Daineko, biocompatibility consultant at Intrinsic Medical Group, to unpack what’s really coming.

This episode covers:

The background and current status of the ISO 10993-1 revision
Why the new version is best seen as an evolution, not a revolution
How the standard pushes further into a risk-based, scientifically justified approach
The link with ISO 14971 and lifecycle thinking
Changes in contact categorization and cumulative exposure
The industry trend toward reducing animal testing through in vitro methods and data-driven justification
How to conduct a gap analysis once the new standard is published
Practical advice on how to prioritize updates without freezing projects or panicking
Real-world examples where process chemicals, not base materials, changed the risk picture
How Intrinsic Medical Group supports companies with biological evaluation, cleanliness, sterilization and reusable devices

If you’re involved in RA/QA, R&D, toxicology, or clinical development, this conversation gives you a practical roadmap for navigating the transition to the new ISO 10993-1.

Who is Monir El Azzouzi?

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post What is changing with the new ISO 10993-1 version 2025 appeared first on Medical Device made Easy Podcast. hamza benafqir

From Zero to One: The journey of a CRO with Helene Quie

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 20 Nov 2025 00:00:00 +0000

In this long-form interview, Helene Quie, founder of Qmed Consulting, shares an inside look at nearly 20 years of experience in clinical and regulatory consulting for medical devices.

This article covers:

Helene’s personal journey from employee to entrepreneur
The early risks and decisions that shaped Qmed’s growth
How the company’s services and markets evolved over time
A deep dive into clinical evidence generation vs equivalence
The seismic impact of EU MDR on clinical strategies
PMCF pitfalls and real-life examples
Working with Notified Bodies and new expectations under MDR
Lessons from projects that didn’t go as planned
The crucial alignment between clinical data and human factors
Practical advice for startups on avoiding top regulatory mistakes
Her vision of the future: RWE, adaptive study designs, digital health & greater regulatory convergence

Who is Monir El Azzouzi?

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post From Zero to One: The journey of a CRO with Helene Quie appeared first on Medical Device made Easy Podcast. hamza benafqir

Medical Device News November 2025 Regulatory Update

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Wed, 12 Nov 2025 23:11:14 +0000

MedBoard

EU

Joint clinical assessment procedure – EU 2025/2086 regulation for reimbursement in the EU: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202502086
Team-NB position paper on Companion diagnostics – Significant changes rules: https://www.team-nb.org/wp-content/uploads/2025/10/Team-NB-PositionPaper-IVDR-Significant-changes-V2.pdf
MDR and IVDR put at risk transplantation – Donor Screening and SoHo preparation: https://www.edqm.eu/documents/52006/162284/PA-PH-TO%20%2824%29%2018%20%E2%80%93%20Risks%20to%20safety%20and%20quality%20in%20donor%20screening%20and%20SoHO%20preparations%20due%20to%20poor%20implementation%20of%20the%20MDR%20and%20IVDR%20%E2%80%93%20CD-P-TO%20Position%20paper%20%E2%80%93%20October%202025.pdf/51d5efb2-4611-13ad-76a0-b5710b371248
- Dedicated proportionate regulatory pathway for Niche fields
- Article 5(5.g) requirements to the highest risk categories (Health institutions to create documentation for the products)
- Update of MDCG guidance on In-house devices to better reflect the operational reality.
- Off-label use and RUO are not falling on Article 5.5 so grey zone.

Team-NB proposal for MDR & IVDR – 5 topics on the agenda: https://www.team-nb.org/nbs-views-on-mdr-and-ivdr-review-process/
- Early dialogue: Use of this to talk to Notified Bodies
- Article 61.10 & WET: Update for more clarity. Narrow the scope.
- Digitalisation: Machine readable documents, AI to support simulations to reduce Animal testing.
- Coding for MD and IVD
- Designation and recertification: For Notified Bodies
- Breakthrough: Coordinated pathway with challenge to generate Clinical Data.
Notified Bodies Count – S New comers for MDR and IVDR:
- SGS Fimko oy (IVDR 19): https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/notifications/1016921
- ICIM S.P.A. (MDR 51) : https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/notifications?organizationRefeCd=EPOS_43747&filter=notificationStatusId:1
- Notice (MDR): https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/notifications/1020121
Standards
- New Harmonized Standards – Clothing and sterilisers: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202502078
- Biocompatibility
- ISO TS 23485: https://www.linkedin.com/posts/melazzouzi_iso13485-iso-medicaldevice-activity-7393773266689228801-d7LM?utm_source=share&utm_medium=member_desktop&rcm=ACoAAABZ07ABDocaBMTLJo8bsl8V3bgNSBIiZuI
UK Reliance with US FDA – Harmonization is ongoing: https://www.gov.uk/government/news/patients-to-benefit-as-uk-and-us-regulators-forge-new-collaboration-on-medical-technologies-and-ai

Service

eIFU with free access -Test it and let us know : https://Easyifu.com
eQMS for a structured Quality Management System – Get your demo: https://eqms-smarteye.com/

Magazine

eMagazine . EMD Mag Free- Are Notified Bodies still the right model: https://easymedicaldevice.com/emd-mag/

ROW

US FDA: Pre-RFD -:Combination product: https://www.fda.gov/media/189466/download
US FDA: QMSR guidelines -: How to create a QMS: https://www.fda.gov/media/189345/download

PODCAST

Podcast review – What happened in October 2025
- Episode 357 – Highlights from La Rentrée du DM 2025: https://podcast.easymedicaldevice.com/357-2/
- Episode 358 – Clinical Evidence under EU MDR – Why so many dossier fail (And how to fix it): https://podcast.easymedicaldevice.com/358-2/
- Episode 359 – Real World Evidence – How to use it right for FDA and EU: https://podcast.easymedicaldevice.com/359-2/
- Episode 360: US Government Shutdown – What FDA can still be doing? Rob Packard: https://podcast.easymedicaldevice.com/360-2/
- Episode 361 – Automatisation of your QA RA Job with AI – Hatem Rabeh: https://podcast.easymedicaldevice.com/361-2/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Medical Device News November 2025 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

Automatisation of your QA RA job with AI

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Wed, 05 Nov 2025 23:34:01 +0000

Artificial Intelligence is reshaping the world of Quality and Regulatory Affairs.
In this podcast episode, Hatem Rabeh joins to demystify how AI can be used — and where it must be handled carefully.

We discuss:

The reality behind “AI replacing QA/RA jobs”
Key tools: n8n, Make, Zapier, OpenAI, and OpenFDA
Building automation workflows for regulatory monitoring and documentation
Managing data privacy, confidentiality, and local vs cloud solutions
The cost, setup time, and risks of AI hallucination
How to use AI safely and ethically in regulated environments

By the end, you’ll know how to build smart workflows that save time, ensure compliance, and keep human oversight where it matters most.

Who is Monir El Azzouzi?

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Automatisation of your QA RA job with AI appeared first on Medical Device made Easy Podcast. hamza benafqir

US Government Shutdown – What FDA can still be doing?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 30 Oct 2025 00:00:00 +0000

US Government Shutdown – What the FDA Can Still Be Doing?

When the U.S. government experiences a shutdown, the consequences ripple across every industry — but for medical device manufacturers, the uncertainty can be alarming.
In this article, Regulatory Expert Rob Packard explores what happens to the U.S. Food and Drug Administration (FDA) during a shutdown, and how it affects global manufacturers.

You’ll learn:

Which FDA activities continue, and which are suspended
How submissions like 510(k), PMA, and De Novo are impacted
What happens to clinical trials, recalls, and ongoing investigations
Whether this situation has happened before and how long it could last
How companies can prepare and what contingency actions to take

Rob also shares practical advice for manufacturers seeking FDA support during this period, as well as insights into how his team can assist in maintaining compliance and communication continuity.

If you’re part of the medical device ecosystem — this is essential reading.

Tags: FDA, Medical Devices, Regulatory Compliance, Quality Management, US Government Shutdown, Rob Packard, Clinical Trials

Who is Monir El Azzouzi?

Links from the Video

https://fda-us-agent.com/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post US Government Shutdown – What FDA can still be doing? appeared first on Medical Device made Easy Podcast. hamza benafqir

Real-World Evidence (RWE): How to Use It Right for FDA and EU MDR Compliance

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 23 Oct 2025 00:01:41 +0000

Real-World Evidence (RWE) is transforming how regulators evaluate medical devices — but many manufacturers still struggle to use it correctly.

In this episode, we break down what RWE really means, how it differs between the FDA and the EU MDR, and how you can design a compliant, global strategy that turns data into regulatory strength.

You’ll learn:

What qualifies as Real-World Data (RWD) and Real-World Evidence (RWE)
How the FDA integrates RWE into premarket submissions (510(k), De Novo, PMA)
How EU MDR uses RWE through PMCF and PMS
The key differences in approach between the two regions
A practical 5-step roadmap to build a compliant RWE strategy
Common pitfalls (bias, poor traceability, privacy issues) — and how to avoid them

Whether you’re in Regulatory Affairs, Clinical Affairs, or Quality Assurance, this episode gives you a clear framework to make Real-World Evidence a competitive advantage, not a compliance headache.

Who is Monir El Azzouzi?

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Real-World Evidence (RWE): How to Use It Right for FDA and EU MDR Compliance appeared first on Medical Device made Easy Podcast. hamza benafqir

Clinical Evidence under EU MDR – Why So Many Dossiers Fail (and How to Fix It)

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 16 Oct 2025 00:42:50 +0000

Since the implementation of EU MDR 2017/745, clinical evidence has become one of the biggest challenges for medical device manufacturers — and a major source of Notified Body nonconformities.

This episode breaks down the root causes behind failed submissions and offers a practical framework to fix them:

Understanding the shift from MDD to MDR (Article 61 & Annex XIV)
Why weak Clinical Evaluation Plans (CEPs) lead to rejection
How to generate and analyze real, device-specific clinical data
Integrating Post-Market Clinical Follow-up (PMCF) into your PMS system
Maintaining a “living” Clinical Evaluation Report across the device lifecycle

By following this checklist, you’ll not only pass your next review but also strengthen your evidence strategy for long-term compliance.

Who is Monir El Azzouzi?

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Clinical Evidence under EU MDR – Why So Many Dossiers Fail (and How to Fix It) appeared first on Medical Device made Easy Podcast. hamza benafqir

Highlights from La Rentrée du DM 2025

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 09 Oct 2025 00:09:50 +0000

The La Rentrée du DM 2025 conference brought together regulators, manufacturers, and industry experts to discuss the evolving landscape of European and global medical device regulation.

Main themes included:

Updates on EU MDR/IVDR and new regulatory initiatives in France
Structured dialogue with Notified Bodies and the harmonization of technical documentation
Post-market discontinuation and the importance of anticipation for patient safety
Eco-design and sustainability, bridging healthcare and environmental responsibility
Software and AI in clinical investigations, and the use of real-world data
Global market access – EU vs US pathways and MDSAP recognition
Technical deep dives into ISO 13485, biocompatibility, usability, and cybersecurity

The consensus was clear: regulatory pressure is increasing, but collaboration, innovation, and anticipation remain the keys to success.

Who is Monir El Azzouzi?

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Highlights from La Rentrée du DM 2025 appeared first on Medical Device made Easy Podcast. hamza benafqir

Medical Device News OCTOBER 2025 Regulatory Update

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Wed, 01 Oct 2025 23:49:30 +0000

Medboard

Europe

Too much Incomplete Tech File – Let’s explain to you how to do it: https://www.team-nb.org/wp-content/uploads/2025/09/Team-NB-PositionPaper-BPG-IVDR-V2-20250903.pdf
2025/1920 on Master UDI-DI – Not only lenses but also Spectacle frames and Ready-to-wear: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202501920
Borderline manual Update – New products included: https://health.ec.europa.eu/document/download/71a87df8-5ca1-4555-b453-b65bdf8de909_en?filename=md_borderline_manual_en.pdf
- red blood cell additive solutions containing adenine
- dual action cream with menthol and capsaicin
- Lactose tablets for vaginal use
- microabrasion dental stain removers
- medical examination table covers
- Mobile sterile air system
EU asks your feedback on EU MDR and IVDR – Enjoy reading some 100 feedbacks: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14808-Medical-devices-and-in-vitro-diagnostics-targeted-revision-of-EU-rules_en

Switzerland

Swissdamed Technical Documentation – XML upload: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank/swissdamed-informationen/swissdamed-technical-documents.html
- Business Rules Swissdamed: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw630_40_002e_pu_swissdamed_business_rules.pdf.download.pdf/BW630_40_002e_PU_swissdamed_Business_Rules.pdf

UK

UK PMS guidance for Report – Template available: https://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements/requirements-of-the-manufacturers-pms-system
- PMSR Template: https://www.gov.uk/government/publications/medical-devices-standardised-format-for-the-post-market-surveillance-report

Magazine

Issue 1: Sept/Oct 2025 – Next one will come November 2025: https://easymedicaldevice.com/emd-mag/

Events

Medtech Conf events – Be listed on the MAP: https://medtechconf.com/events-map-2/

EasyIFU

Free trial for eIFU with EASYIFU – Compliant EU 2025/1234: https://easyifu.com

ROW

US FDA Computer System Assurance – SOP offered on the show notes: https://www.fda.gov/regultory-information/search-fda-guidance-documents/computer-software-assurance-production-and-quality-system-software-0
https://mailchi.mp/easymedicaldevice/sop-computer-software-assurance
Malaysia affiliate member of MDSAP – What does it change?: https://portal.mda.gov.my/index.php/announcement/1636-malaysia-is-now-mdsap-medical-device-single-audit-program-mdsap-member
Australia Essential Principles Checklist Update -: Update the templates V1.2: https://www.tga.gov.au/resources/resource/checklists/essential-principles-checklist
Egypt guidance to import your devices – Medical Devices, Accessories, IVD:

Podcast

Episode 353: Cybersecurity in Medical Devices: What QA/RA must do Today: https://podcast.easymedicaldevice.com/353-2/
Episode 354: From Surgeon to CEO: Building Neurogyn AG: https://podcast.easymedicaldevice.com/354-2/
Episode 355: Postmarket Surveillance for SaMD and AI: https://podcast.easymedicaldevice.com/355-2/

Easy Medical Device Service

Support for Consulting (QA RA projects)
Support for Authorized Representative and Market Access
Integration to an eQMS

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Medical Device News OCTOBER 2025 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

Post-Market Surveillance for Software and AI Devices

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Wed, 24 Sep 2025 22:52:35 +0000

Post-Market Surveillance for Software & AI Devices – A QA/RA Guide

Software evolves with updates. AI models may even change with real-world data. That makes Post-Market Surveillance (PMS) for digital medical devices very different from traditional hardware.

In this article, based on the podcast episode, we cover:

How PMS differs for software, cloud, and AI-based devices
Usage monitoring & anomaly detection through dashboards and KPIs
Revalidation of updates and retrained AI algorithms
Regulatory frameworks: EU MDR/IVDR, FDA’s PCCP, IMDRF guidelines
Supplier and infrastructure considerations
A step-by-step PMS workflow for QA/RA teams
Real-world case study on AI performance drift

We conclude with a practical checklist to help QA/RA teams ensure compliance while keeping patients safe.

Who is Monir El Azzouzi?

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Post-Market Surveillance for Software and AI Devices appeared first on Medical Device made Easy Podcast. hamza benafqir

From Surgeon to CEO: Building NEUROGYN AG Professor Marc Possover’s Journey

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 18 Sep 2025 00:00:00 +0000

The journey from a successful surgical career to the leadership of a medical company is far from ordinary. Yet for Prof. Marc Possover, this evolution felt like a natural extension of his life’s mission: to improve patient outcomes and expand access to advanced treatments in pelvic neurosurgery.
In this exclusive episode of the Medical Device Made Easy Podcast, host Monir El Azzouzi invites Prof. Possover to share his story—one that blends clinical excellence, entrepreneurial vision, and a deep commitment to education.

A Career Built on Medical Breakthroughs

Prof. Possover is internationally recognized as a pioneer in neuropelveology, a specialty dedicated to treating complex pelvic nerve disorders. Over the years, he has developed innovative procedures that offer hope to patients suffering from chronic pain and dysfunctions once considered untreatable. But his ambition has always reached beyond the operating room. By founding his own medical company, he sought to transform groundbreaking surgical techniques into accessible, reproducible therapies that benefit patients worldwide.

Why a Surgeon Became a CEO

Moving from the precision of surgery to the strategic demands of business might seem like a dramatic shift, but for Prof. Possover it was a continuation of his mission. Becoming a CEO meant taking responsibility not only for individual patients but for the future of the treatments themselves. Leadership allowed him to guide product development, secure resources, and create an ecosystem where new therapies could flourish well beyond his own practice.
As he explains in the podcast, “At some point I will retire—or die—but what will remain are the colleagues I trained.” His decision to lead a company ensures that his techniques will survive and continue to evolve, creating impact that outlasts any single career.

Patient Education as a Driving Force

Throughout the conversation, Prof. Possover emphasizes the vital role of patient education. When patients are aware of new treatment options, they actively seek qualified specialists, creating a natural demand for innovation. This patient-driven movement pressures the medical community to adopt cutting-edge solutions and ensures that life-changing therapies reach those who need them most.
By offering information sessions and open discussions, he empowers patients to become advocates for their own health—transforming the doctor–patient relationship into a true partnership.

Building a Global Legacy Through Training

Prof. Possover’s passion for teaching is at the heart of his work. Through the International School of Neuropelveology (ISNP), he trains surgeons from around the world in these advanced procedures. Every surgeon he educates becomes a multiplier of knowledge, capable of treating patients in regions far beyond his own reach.
This dedication reflects a philosophy that medicine’s greatest achievements are collective. A breakthrough is only meaningful if it can be shared, replicated, and improved upon by future generations.

Lessons for Medical Professionals and Entrepreneurs

This conversation is more than an inspiring personal story—it is a roadmap for anyone seeking to combine medicine, innovation, and business.

Clinical expertise can fuel entrepreneurship when paired with strategic thinking.
Patient awareness accelerates adoption, creating a powerful feedback loop between innovation and demand.
Education builds permanence, ensuring that treatments survive beyond the careers of their pioneers.

Whether you are a surgeon curious about entrepreneurship, a MedTech innovator looking for guidance, or a healthcare professional eager to create lasting change, Prof. Possover’s journey demonstrates that the skills learned in medicine—discipline, precision, and empathy—are the very qualities that can drive successful leadership.

In this podcast, Monir El Azzouzi and Prof. Marc Possover invite you to reflect on the future of healthcare. Their discussion shows that true medical progress lies not only in discovering new treatments, but also in ensuring that knowledge is shared, patients are informed, and innovations continue to thrive long after their creators have left the stage.

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post From Surgeon to CEO: Building NEUROGYN AG Professor Marc Possover’s Journey appeared first on Medical Device made Easy Podcast. hamza benafqir

Cybersecurity in Medical Devices – What QA/RA Must Do Today

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Wed, 10 Sep 2025 23:51:31 +0000

Cybersecurity in Medical Devices – A QA/RA Perspective

Cybersecurity is often seen as an IT or engineering issue—but in reality, regulators and auditors turn to QA and Regulatory Affairs professionals for evidence.
In this article (based on the podcast episode), we explore:

How to prepare cybersecurity documentation for audits and inspections
Building post-market processes for vulnerability handling and reporting
Linking cybersecurity with standards (ISO 13485, ISO 14971, IEC 62304, ISO 27001…)
Managing supplier and open-source component risks
Implementing and maintaining an SBOM
Key trends like the NIS2 Directive and the EU AI Act

We finish with a practical checklist for QA/RA teams to assess their readiness today.

Cybersecurity isn’t about perfection—it’s about showing regulators you are in control.

Who is Monir El Azzouzi?

The post Cybersecurity in Medical Devices – What QA/RA Must Do Today appeared first on Medical Device made Easy Podcast. hamza benafqir

Medical Device News September 2025 Regulatory Update

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 04 Sep 2025 23:44:40 +0000

Medboard

EUROPE

Guidance on the implementation of the Master UDI-DI – MDCG 2024-14 – rev.1 : https://health.ec.europa.eu/document/download/c8c6cca5-460e-410e-a325-be08bfc7dea6_en?filename=mdcg_2024-14_en.pdf
Updated – Notified bodies survey on certificates under MDR and IVDR: https://health.ec.europa.eu/document/download/59b9d90e-be42-4895-9f6f-bec35138bb0a_en?filename=md_nb_survey_certifications_applications_en.pdf
- There’s a significant backlog: far more applications submitted than certificates issued, especially for IVDs.
- Time for certification: between 13 to 18 months on average
- Delay due to application missing critical information and refusal due to submission outside NB scope
- No transparency on capacity
Germany new radiation protection regulation – Start July 1st, 2025: https://www.bfarm.de/DE/Arzneimittel/Klinische-Pruefung/Strahlenschutz/_artikel.html?nn=986770
- If device emit radiation and need clinical investigation in germany:
  - Include a radiation risk assessment in your clinical investigation dossier
  - Coordinate with Radiation protection authorities
  - Update investigator brochure and patient information
  - Stricter Monitoring & Reporting
  - Impact on Timelines
- So stricter documentation, more authorities involved and longer approval times

MHRA launches Route B notification pilot Clinical trials regulations rollout: https://www.gov.uk/government/news/mhra-launches-route-b-notification-pilot-as-part-of-clinical-trials-regulations-rollout – https://www.gov.uk/guidance/notify-mhra-about-a-clinical-investigation-for-a-medical-device

Switzerland

New in Swissdamed – Medical Device registration with UDI Device Module: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank/swissdamed-informationen/registrierung-mepprodukte-moeglich.html
- 1 july-2026

Magazine

Easy Medical Device Mag – Your QA RA Magazine: https://mailchi.mp/easymedicaldevice/emdmag1

Podcast:

Best 40 Medical Device Podcast – Thanks: https://www.millionpodcasts.com/Medical-Device-podcasts/

REST OF THE WORLD

SaMD and/or Artificial Intelligence on the spotlight – All countries want their regulation on it:
- USA: PCCP – https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
- SFDA: Workshop September 9th: https://www.sfda.gov.sa/en/workshop/4387139
- TGA: Understanding regulation of software-based medical devices: https://www.tga.gov.au/resources/guidance/understanding-regulation-software-based-medical-devices#samd-and-ai-medical-device-compliance
- SAHPRA: Regulatory Requirements of AI/ML: https://www.sahpra.org.za/document/regulatory-requirements-of-artificial-intelligence-and-machine-learning-ai-ml-enabled-medical-devices/
Medical Device or Wellness device – Choose your side: https://www.sfda.gov.sa/sites/default/files/2025-08/MDS-G027.pdf

The post Medical Device News September 2025 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

The good, bad and uglyof using AIfor QA RA Compliance

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 28 Aug 2025 00:00:00 +0000

Artificial Intelligence is no longer just a buzzword — it’s already finding its way into Quality Assurance (QA) and Regulatory Affairs (RA) in the medical device industry. But what does this mean for compliance professionals? Is AI a powerful tool to accelerate regulatory processes, or a risky shortcut that could jeopardize compliance?

In this new episode of the Medical Device Made Easy Podcast, Monir El Azzouzi sits down with RJ Kedziora (Estenda) to explore the opportunities and risks of using AI in regulatory compliance. Together, they discuss:

Why more QA/RA teams are experimenting with AI tools like ChatGPT, Gemini, Claude, and Grok
How to integrate AI into different product design and regulatory phases
The role of Prompt Engineering and why it matters in compliance
Practical tips for creating effective AI prompts
The warnings and risks you should keep in mind when relying on AI
How agencies like the FDA are beginning to explore AI for dossier reviews

If you want to stay ahead in the world of medical device compliance, this conversation is a must-listen.

The post The good, bad and uglyof using AIfor QA RA Compliance appeared first on Medical Device made Easy Podcast. hamza benafqir

Medical Device Software Versioning

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 21 Aug 2025 00:00:00 +0000

Managing Software Updates in Medical Devices: Best Practices & Pitfalls

In the world of medical devices, software updates are never just technical tweaks—they directly impact patient safety, regulatory compliance, and product reliability. Managing these updates correctly is a challenge many manufacturers face, especially with evolving standards like ISO 13485 and IEC 62304.

In this episode of our podcast, we dive into the critical aspects of software update management for medical devices:

Versioning strategies – How to classify bug fixes, minor updates, and major releases, and the role of semantic versioning in regulated environments.
Documentation & traceability – Why proper version control and documentation are essential for audits and compliance.
Communication with stakeholders – Best practices for release notes, change logs, and informing users, regulators, and internal teams.
Common pitfalls – Mistakes that lead to compliance risks and how to avoid them.
Pro tips & resources – Actionable recommendations to strengthen your update and versioning strategy.

Whether you are a software engineer, QA/RA professional, or regulatory affairs manager, this episode will give you practical tools and insights to build a robust, compliant, and audit-ready update process.

Listen now and discover how to master the balance between innovation, safety, and compliance in medical device software.

The post Medical Device Software Versioning appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

From Zero to One How to collaborate with clients

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 14 Aug 2025 07:53:18 +0000

From Zero to One: Mastering Client Collaboration in Consulting
Starting your consulting journey can feel overwhelming—finding clients, building trust, and delivering results all at once. In my conversation for the Medical Device Made Easy podcast, I share my personal path: from my early days in engineering to creating Simply Medica, and the lessons learned along the way.
We discuss how to:

Build credibility before calling yourself a consultant
Turn your first project into a stream of referrals
Use networking (both in-person and online) to grow
Balance expertise with passion to create real impact
For anyone starting out—or looking to strengthen client relationships—this is your roadmap from zero to one.

The post From Zero to One How to collaborate with clients appeared first on Medical Device made Easy Podcast. hamza benafqir

From Zero to One: Becoming a Medical Device auditor

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Fri, 08 Aug 2025 00:55:42 +0000

Have you ever wondered what it’s really like to work as a medical device consultant or ISO 13485 auditor? In this episode of the Medical Device Made Easy Podcast, I sit down with Adam Isaac, an industry expert who made the leap from engineering student to successful entrepreneur in the MedTech world.

Adam’s journey is a masterclass in career transformation. Without prior experience in Regulatory Affairs & Quality Assurance (RAQA), he navigated the complex world of compliance and built a thriving consultancy business — all without traditional advertising.

What you’ll discover in this episode:

How Adam transitioned into RAQA with no previous background
The real day-to-day life of an ISO 13485 auditor — separating myths from reality
Common mistakes consultants and auditors should avoid
What clients truly value when hiring a consultant
How to grow your consulting business organically
Adam’s next big step: creating an AI-powered audit tool to transform compliance work

Whether you’re just starting your career in medical devices or thinking about launching your own consultancy, this episode offers honest, practical insights you won’t find in any textbook.

Listen now and gain a realistic perspective on what it takes to succeed in the highly regulated MedTech industry.

The post From Zero to One: Becoming a Medical Device auditor appeared first on Medical Device made Easy Podcast. hamza benafqir

From Zero to One – Should You Work with a QA/RA Recruiter? | Podcast Episode

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 31 Jul 2025 00:00:00 +0000

In our latest podcast, we dive deep into the recruitment world with Mitch, a founder and specialist recruiter in Quality Assurance & Regulatory Affairs (QA/RA). If you’re a hiring manager, candidate, or aspiring recruiter in the life sciences or medtech industries, this episode is packed with honest insights and practical advice.

What you’ll learn:

Why Mitch chose to specialize in QA/RA
The tension between client expectations and candidate realities
How recruiters make their revenue (yes, we ask the money question!)
Whether promoting open positions is still a challenge in 2025
Mitch’s personal journey—education, family, and the struggles of building a business from scratch
What he would do differently if he had to start again

Whether you’re considering using a recruiter or dreaming of launching your own hiring firm, this episode will help you understand what it really takes to go “from zero to one.”

Listen now and subscribe to our podcast to never miss a new episode!

Linkedin: https://www.linkedin.com/in/mitchrobbins/
Website: https://theanthonymichaelgroup.com/

The post From Zero to One – Should You Work with a QA/RA Recruiter? | Podcast Episode appeared first on Medical Device made Easy Podcast. hamza benafqir

Why Switch to eIFU? Top Regulatory & Operational Benefits Explained for Medical Device Manufacturers

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 24 Jul 2025 00:18:57 +0000

Everything You Need to Know About EU Regulation 2025/1234 and the Future of eIFU for Medical Devices

On July 16, 2025, a pivotal regulatory update—EU 2025/1234—comes into effect, expanding the use of electronic Instructions for Use (eIFU) to a much broader range of medical devices and accessories. Unlike previous regulations that limited eIFU to implantables or certain fixed devices, this amendment now authorizes the use of eIFU for all professional-use medical devices, including those covered by transitional provisions and even non-medical products listed under Annex XVI.

This shift marks a turning point in the digitization of compliance documentation in the medical device industry. In this video, we walk you through the full impact of the new regulation, as well as the operational benefits and responsibilities that come with adopting eIFU.

What the regulation says:

Manufacturers are allowed to provide eIFUs for professional-use devices, as long as the device is not likely to be used by laypersons.
For any device that might be used at home or by a non-professional, a paper IFU is still mandatory.
All versions of an eIFU—current and obsolete—must be hosted securely and remain accessible to authorities on request.
The URL of the eIFU must be registered in EUDAMED’s UDI database once that requirement becomes mandatory.

Top 5 reasons why switching to eIFU makes sense:

Broader regulatory permission
This update grants manufacturers the freedom to digitize IFUs across their entire product line, simplifying regulatory planning and execution.
Significant cost savings and faster updates
With eIFUs, there’s no need for printing, translation management across packaging batches, or physical distribution—everything can be updated instantly online, cutting costs and time-to-market.
Improved traceability and audit readiness
Digitally managing eIFUs ensures version control, easy access for auditors, and a clean digital trail that supports internal QA systems.
Better experience for healthcare professionals
Healthcare professionals prefer electronic formats for their speed, searchability, and multilingual options—making your devices more user-friendly.
Alignment with the EU’s digital vision
By linking eIFUs directly with EUDAMED and UDI databases, you align your business with the evolving regulatory ecosystem and future-proof your documentation process.

But eIFU is not a one-size-fits-all solution. You still need paper IFUs in key scenarios:

If your device could be used by laypersons, you must provide a paper version.
In low-connectivity settings, such as field hospitals or rural clinics, physical IFUs may be more reliable.
Adopting eIFU requires full platform readiness, including hosting, backups, multilingual versions, and internal QA validation.
Regulatory responsibility is now entirely on the manufacturer—including website uptime, version archives, and EUDAMED linkage.
Some stakeholders—including auditors and hospitals—still prefer traditional paper documentation, which could delay full adoption.

Watch our video to get a complete overview of the regulation and see how EasyIFU helps you implement a compliant, secure, and future-ready eIFU process.is is essential for RA/QA teams, product managers, and any manufacturer operating under MDR.

The post Why Switch to eIFU? Top Regulatory & Operational Benefits Explained for Medical Device Manufacturers appeared first on Medical Device made Easy Podcast. hamza benafqir

Quality & Regulatory in MedTech – Interview with Pardeep Kaur

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 17 Jul 2025 01:09:19 +0000

Quality & Regulatory in MedTech – Interview with Pardeep Kaur

Background: From IT in India to MedTech in Norway

You have a pretty fascinating background – you studied computer applications/IT back in India and now you’re a Quality/Regulatory Manager in the Norwegian medtech scene. Can you walk us through that journey? How did you go from an IT degree in India to working with medical device regulations in Norway? (What prompted the move and career change?)

What were the biggest challenges when you switched into the medical devices field? For example, was there a steep learning curve with all the medical and regulatory jargon?

And conversely, do you think your IT background gives you any unique advantages in QARA? (Maybe in handling technical documentation or bringing a fresh perspective?)

Day-to-Day as a QARA Manager

Let’s talk about what a QARA Manager actually does. What does a typical day or week look like for you as a Quality and Regulatory Affairs Manager? (For instance, are you reviewing a lot of documents, meeting with engineers, training colleagues, dealing with audits… all of the above?)

It would be great if you could mention some of the tools or software you use regularly. Are there specific QMS (Quality Management System) tools, document control systems, or even simple spreadsheets that are part of your daily routine?

We often hear that QA/RA folks are like the “internal police” in a company – some colleagues think you just spend days reading boring regulations and chasing them to follow rules (laughs). How true or untrue is that stereotype? How would you describe the role to someone who thinks it might be dry or overly bureaucratic?

On that note, an article I read actually said quality and regulatory roles are among the most dynamic and diverse in a company. You have to know a bit of everything – the tech, the laws, writing skills, you name it. What parts of the QARA role do you find most challenging, and which parts are the most rewarding?

(For example, is it challenging that the scope is so broad – one moment you’re deep in engineering specs, next moment you’re updating a regulatory policy? And rewarding perhaps when a product finally gets approved or when you prevent a big issue?)

First MedTech Role at Hy5Pro AS

Let’s dive into your work experiences. Your first QARA role in Norway was at Hy5Pro AS, a startup developing a pretty cool product – a hydraulic prosthetic hand for amputees. What was it like stepping into Quality/Regulatory at a company making robotic hands?

(Feel free to explain what Hy5Pro’s product was and your role there, e.g. implementing the quality system, getting certifications, etc.)

Do you have any memorable anecdotes from Hy5Pro? Perhaps a big challenge you faced early on or a funny incident while working on the prosthetic hand project. For instance, a lot of startups at that stage are trying to get their first ISO 13485 certification or pass initial regulatory hurdles – any story around that?

(e.g. “the day the auditors came for ISO certification” or a time something went wrong and how the team fixed it – anything that was a learning moment for you.)

Leading QARA at RemovAid AS

After Hy5, you moved on to RemovAid AS, which is another fascinating company – they created a device for removing contraceptive implants (a small gadget to help doctors remove those under-the-skin birth control implants). And I believe you were Head of Quality Assurance & Regulatory Compliance there. What were your main responsibilities at RemovAid, and how did it differ from your previous role?

RemovAid’s product is a Class IIa medical device and was CE-marked under the new EU Medical Device Regulation. That sounds like a huge regulatory achievement. Can you share a proud moment from your time at RemovAid? For example, leading the company to ISO 13485 quality certification, or getting that CE approval, or the first time the device was manufactured at scale.

(We saw on LinkedIn you celebrated the first RemovAid device coming off a high-volume production line – feel free to tell that story!)

On the flipside, any tough or funny moments while at RemovAid? Perhaps juggling multiple roles in a small startup, or an unexpected problem that popped up (like a quirky product test failure or a documentation marathon just before a deadline)?

RemovAid is in women’s health tech. Did working on a product aimed at female healthcare bring any special perspective or motivation for you? (Given it’s about making contraceptive care easier – that’s quite impactful.)

Consulting Experience at LINK Medical

Now, currently you’re working at LINK Medical as a Medical Device Manager in their Quality/Regulatory team. So you went from being in-house at startups to a consulting role where you support multiple companies. What has that transition been like? How is life as a consultant different from working within a single company?

I imagine as a consultant you get to see a variety of projects – different devices, different teams – which can be exciting. Can you share any interesting experiences from your consulting work so far? Maybe an example of a cool project you helped on, or a common mistake you see companies making with QARA that you help fix, or even a humorous experience of jumping into a new company’s project mid-stream.

Also, how do you manage your time and sanity when juggling multiple clients or projects? That sounds challenging – any personal tricks you’ve learned for staying organized when everyone needs your expertise at once? (laughs – “the consultant life”)*

Diversity and International Career Insights

I’d like to touch on diversity and your international experience. You’re a woman in the medtech industry and you’ve built your career across two countries and cultures. Have you faced any unique challenges as a woman working in medical devices and QARA? And what about being an international professional – any cultural adjustments or advantages you’ve noticed working in Norway compared to India?

The medtech industry, especially in leadership, still isn’t very diverse – I read that less than a quarter of executive roles in medtech are held by women. How do you feel about the state of diversity in our field? Are things improving, and have you seen progress during your career?

What advice would you give to companies or teams to foster a more inclusive environment, especially in fields like quality and regulatory? (Since those teams often work with all departments, they can influence company culture too.)

Rapid-Fire Round

Host: Okay, Pardeep, to wrap up on a fun note, we have a rapid-fire round! I’ll ask you a series of quick questions and you answer with the first thing that comes to mind. Ready? (brief pause) Go!

Question 1: What’s one thing about your job that most people would be surprised to learn?

Question 2: What’s the coolest medical device or gadget you’ve worked on or seen so far?

Question 3: Are you team coffee or tea? (What fuels your workdays?)

Question 4: Is there a quality/regulatory jargon or acronym you think is funny or confusing (and what does it actually mean)?

Question 5: If you weren’t in QARA, what alternate career could you see yourself in?

Question 6: What’s one Norwegian word or phrase you’ve picked up that you love to use? (Bonus: translate it for us!)*

Question 7: If your career journey were made into a movie title, what would it be? (Just for fun!)

(Guest gives rapid-fire answers with laughter and brief commentary.)

Advice and Closing

Now, before we sign off, I want to circle back to a more reflective note. What advice or words of inspiration do you have for junior professionals, students, or even folks thinking of switching careers into Quality and Regulatory in medtech? For someone listening who says, “This sounds interesting but also a bit overwhelming,” how can they prepare and what should they expect?

(For example, should they get familiar with certain regulations or take courses? Find a mentor? Be ready to continually learn? Share any practical tips.)

And maybe equally important, what should they not be scared of? People might think “Oh, I’m not a science or law expert, can I do this?” – any encouragement to help them overcome that hesitation?

Podcast Interview Questions for Pardeep Kaur (Reg compliance manager Oslo University Hospital)

Welcome & Setup

Can you briefly introduce yourself and describe your current role as a Quality & Regulatory Affairs Manager?

Career Journey

How did you go from earning a Computer Applications/IT degree in India to a QARA career in Norway?

What motivated you to switch into medical device regulations, and what were the biggest initial challenges?

In what ways has your IT background helped you excel in QARA?

Day-to-Day Responsibilities

What does a typical day or week look like for you as a QARA Manager?

Which tools or software (QMS systems, document controls, etc.) do you rely on most?

Is it true that QA/RA professionals are the “internal police”? How would you describe the role to someone who thinks it’s all paperwork?

Which aspects of QARA do you find most challenging, and which are the most rewarding?

Hy5Pro AS Experience

What was it like implementing QARA at Hy5Pro, developing a hydraulic prosthetic hand?

Can you share a memorable “learning moment” or funny anecdote from your time there?

RemovAid AS Experience

At RemovAid, you led Quality & Regulatory for a Class IIa implant-removal device—what were your core responsibilities?

Describe a proud milestone (e.g., ISO 13485 certification or CE marking) and the story behind it.

Any unexpected or humorous challenges you overcame in that role?

How did working on a women’s health product impact you personally?

LINK Medical Consulting

How has transitioning to a consulting role at LINK Medical differed from in-house QARA positions?

What’s a standout project or recurring compliance issue you help clients solve?

How do you stay organized when juggling multiple clients and deadlines?

Diversity & International Insights

As a woman in medtech QARA, have you faced any unique challenges or opportunities?

What cultural adjustments did you experience moving from India to Norway?

How can medtech teams become more inclusive, especially in QA/RA?

Rapid-Fire Round
(Answer quickly with the first thing that comes to mind.)

One surprise fact about your job?

Coolest device or gadget you’ve worked on or seen?

Favorite (or funniest) QARA acronym—what does it mean?

Alternate career you might have chosen?

Norwegian word or phrase you love—translate it for us!

If your career were a movie title, what would it be?

Closing Advice

What practical steps should students or career-changers take to break into QARA?

What misconceptions shouldn’t they be afraid of when considering this field?

The post Quality & Regulatory in MedTech – Interview with Pardeep Kaur appeared first on Medical Device made Easy Podcast. hamza benafqir

From Zero to One: Creating your Consulting Firm

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 10 Jul 2025 00:00:00 +0000

Guest: Stefan Bolleininger

Title: From Zero to One: Creating your Consulting Firm

Logo: Be on Quality

Telling the story behind Be on Quality,

the challenges for you,
the way you did grow the business,
the things you would do differently
cost

Sharing also the life of a CEO that did start this project.

How many hours are you working,
zis it easy to disconnect,
what are your fears…. AI
What’s next for Be on Quality

Link:

Be on Quality: https://www.be-on-quality.com/
Stefan Bolleininger Linkedin: https://www.linkedin.com/in/stefan-bolleininger-3a717028/

Quick recap

Stefan shared his entrepreneurial journey from working in automotive quality management to founding and growing his medical device consulting company, which was later acquired by a French engineering firm and merged with his sister company in Switzerland. Through discussions with Monir about his business experiences, they explored topics including customer relationships, pricing strategies, and the challenges of managing company growth while maintaining quality and communication. Stefan emphasized the importance of taking risks, maintaining industry connections, and leveraging technology while emphasizing the value of human interaction in their field, particularly in the context of his company’s recent acquisition and expansion.

Next steps

Stefan to continue leading Be on Quality through the merger with Volker group.

Be on Quality team to expand services, particularly in AI implementation for medical devices and clinical trial areas.

Stefan to maintain transparent communication with employees regarding company changes and future plans.

Be on Quality to collaborate with sister company Be on Conception in Switzerland on combination products.

Stefan to continue balancing work responsibilities with personal time, including occasional “beach visits”.

Stefan to maintain regular revenue and project load calculations to mitigate fears about project availability.

Stefan to focus on providing value and mentorship to senior consultants and business area leads.

Be on Quality team to continue using AI as a tool to enhance work efficiency without replacing human expertise.

Summary

Journey to Medical Device Consulting

Stefan shared his journey from working in automotive quality management to founding his own medical device consulting company, Be on Quality GmbH, after being encouraged by his mentor. He described how he grew the business through referrals and local connections in Nuremberg, where there are approximately 500 medical device companies. Stefan emphasized that taking risks is essential for growth, particularly when transitioning from freelance work to company ownership, and noted that his supportive wife’s encouragement was crucial since he was the first entrepreneur in his family.

Customer Retention Strategies in Medical Devices

Stefan emphasized the importance of maintaining connections and visibility in their industry, highlighting that cold calling and direct knocking do not work effectively. He shared experiences of past customer relationships, including a challenging project where deliverables did not meet the client’s expectations, leading to a contract that could not be salvaged. Stefan stressed the need for clear communication and alignment with customer expectations to ensure long-term customer retention, which is crucial in their competitive medical device regulatory market. Monir suggested a mechanism for filtering potential customers with a small initial project to assess compatibility and expectations, which Stefan acknowledged as a useful approach, especially for startups and small companies.

Business Growth and Team Dynamics

Stefan discussed his business challenges, including a difficult working relationship with a former colleague that led to a split, but emphasized that such challenges are part of growing a company. He reflected on how his company, which started in 2017 and began as a freelance business in 2013, has grown to 27 employees, with his team sometimes advising him to focus on organic growth rather than taking on new projects. Stefan noted that while MDR hasn’t significantly accelerated his business, he finds working with technology and engineering companies most comfortable, though his team has expertise across various product types.

Client Pricing and Documentation Insights

Stefan and Monir discussed pricing challenges with clients, where Stefan noted that while some clients negotiate prices, none have shown negative emotions about pricing. They also discussed the high costs of notified bodies and the importance of creating high-quality technical documentation to reduce review rounds. Stefan shared his perspective as CEO of Be on Quality, revealing he works approximately 50 hours per week and enjoys his job, though he prefers the concept of office time and home time rather than work-life balance.

AI’s Role in Human Work

Stefan shared his professional journey, particularly in housing and installation projects, and expressed concerns about the evolving nature of his role as the company grows. He acknowledged his fear of not being able to provide sufficient mentoring to his colleagues, despite his efforts to maintain a hands-on approach. Stefan also discussed his perspective on artificial intelligence, emphasizing its potential to enhance rather than replace human work, and highlighted the importance of human interaction in their industry. Monir encouraged Stefan to view AI as a tool to assist and inspire, rather than relying on it systematically for all tasks.

Strategic Company Acquisition Success

Stefan discussed the recent acquisition of his company by a larger partner, which he described as a strategic move to expand services and reach. He emphasized that the decision was made after thorough discussions with his team, who supported the merger despite initial concerns about changes. Stefan highlighted the importance of trust and open communication within the company, which he believes contributed to the successful transition. The acquisition has allowed his company to grow and make a bigger impact, with additional resources and expertise from the partner company.

The post From Zero to One: Creating your Consulting Firm appeared first on Medical Device made Easy Podcast. hamza benafqir

Medical Device News JULY 2025 Regulatory Update

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 03 Jul 2025 00:24:11 +0000

Medboard: https://www.medboard.com/

EUROPE

new eIFU rules – Let’s save some paper print: https://eur-lex.europa.eu/eli/reg_impl/2025/1234/oj
- https://health.ec.europa.eu/latest-updates/commission-simplifies-instructions-use-medical-devices-further-digitalise-healthcare-systems-2025-06-25_en
- EasyIFU.com
MDR + IVDR + AI Act = MDCG 2025-6 – Any other legislation to add?: https://health.ec.europa.eu/document/download/b78a17d7-e3cd-4943-851d-e02a2f22bbb4_en?filename=mdcg_2025-6_en.pdf
MDCG 2025-5: IVDR Performance Study – Masterclass to understand Performance Study: https://health.ec.europa.eu/document/download/f22f559b-dee5-43b4-9595-3ccdcca9f7ad_en?filename=mdcg_2025-5_en.pdf
Team-NB. Software Qualification (IVDR) clarification – Translation of the MDCG 2019-11: https://www.team-nb.org/wp-content/uploads/2025/06/Team-NB-PositionPaper-Software-Qualification-under-the-IVDR-V2-20250627.pdf
- MDCG 2019-11: https://health.ec.europa.eu/document/download/b45335c5-1679-4c71-a91c-fc7a4d37f12b_en?filename=mdcg_2019_11_en.pdf
CECP: Mechanical Respiratory – Result is not good: https://health.ec.europa.eu/document/download/80f2432d-a9da-48ae-8ebb-0054b4922033_en?filename=cecp-2025-0000232089_opinion_en.pdf
MDCG 2025-4 Software delivered with Online Platforms – Are your apps conform: https://health.ec.europa.eu/document/download/ec9b0f40-7f82-43a7 -b833-ebd45b772eae_en?filename=mdcg_2025-4_en.pdf
PROJECT NAME: COMBINE – Clinical Trials with Medicine and IVDs: https://ec.europa.eu/newsroom/sante/newsletter-archives/64447
- https://health.ec.europa.eu/medical-devices-topics-interest/combined-studies/combine-project-1-pilot-all-one-coordinated-assessment_en

UK

UK PMS mandatory since June 16th, 2025 – Learning starts: https://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements#full-publication-update-history
- Press Release: https://www.gov.uk/government/news/first-major-overhaul-of-medical-device-regulation-comes-into-force-across-great-britain
- Periodic Safety Update Report: https://www.gov.uk/government/publications/medical-devices-periodic-safety-update-report-psur
- Example of reportable incidents: https://www.gov.uk/government/publications/medical-devices-examples-of-reportable-incidents
- MORE Guide update: https://assets.publishing.service.gov.uk/media/6847fc9c944a600f13bcb852/User_Reference_Guide___MORE_Incident_Submissions.pdf
- Document for implementation of Data: https://www.gov.uk/government/publications/documentation-for-implementation-of-data-requirements-under-the-new-post-marketing-surveillance-regulations

ROW

USA
- UDI for combination products – What are the rules?: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/unique-device-identifier-requirements-combination-products
- Conducting Remote Reg Assessment – SQuestion and Answers: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/conducting-remote-regulatory-assessments-questions-and-answers
- Transfer of Premarket Notification (510k) – Questions & Answers: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/transfer-premarket-notification-510k-clearance-questions-and-answers
CANADA
- Canada is cancelling all MDELs – Only if you don’t confirm the Annual License Review: https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/medical-devices-compliance-bulletin/cancellation-non-compliance-annual-review-requirements-2025.html
Saudi Arabia
- SFDA Webinar: Risk Management File – July 8th, 2025 10 AM Saudi Time: https://www.sfda.gov.sa/en/workshop/3868398

Podcast

Episode 340 – Software as a Medical Device: Beginner’s guide to Testing and Validation: https://podcast.easymedicaldevice.com/340-2/
Episode 341 – Notified Bodies raise concern on Risk Grading: https://podcast.easymedicaldevice.com/341-2/
Episode 342: From Zero to One: SaaS Founder’s First Five Years: https://podcast.easymedicaldevice.com/342-2/

The post Medical Device News JULY 2025 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

From Zero to One: SaaS Founder’s First Five Years

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Wed, 25 Jun 2025 23:32:01 +0000

From Zero to One: SaaS Founder’s First Five Years with Ivan Perez Chamorro

In this exciting episode of the Easy Medical Device Podcast, we welcome Ivan Perez Chamorro, the CEO and founder of Medboard, a fast-growing SaaS company. Ivan takes us behind the scenes of his entrepreneurial journey, from starting with zero to building a thriving business in the tech world.

In this candid conversation, Ivan dives into:

The story behind Medboard and how it all began from scratch

The challenges he faced along the way and how he successfully scaled the business

The lessons learned and the things he would do differently if given a second chance

A day in the life of a CEO: How many hours does Ivan work? How does he disconnect?

The personal fears and struggles that come with being a founder, and how to overcome them

And of course, what’s next for Medboard—the exciting plans ahead!

This episode offers an honest, no-holds-barred look at the journey of building a successful SaaS company and what it takes to lead with passion, persistence, and resilience.

Don’t miss this insightful discussion! Tune in now and hear firsthand what it takes to take a business from zero to one.

Listen to the full episode here: Medboard

Social Media to follow

ivan-perez-chamorro linkedin: https://www.linkedin.com/in/ivan-perez-chamorro/
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post From Zero to One: SaaS Founder’s First Five Years appeared first on Medical Device made Easy Podcast. hamza benafqir

Notified Bodies raise concern on Risk Grading

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Wed, 18 Jun 2025 23:20:07 +0000

Risk Grading Gone Wrong: How to Fix Your Severity, Occurrence & Detection Strategy Before Your Notified Body Does

Risk Management mistakes that could cost you your certification!

In this episode of the Medical Device Made Easy Podcast, Monir El Azzouzi tackles one of the most common and preventable Notified Body non-conformities: flawed risk grading strategies.
If your team is still using overcomplicated matrices or adjusting severity post-mitigation — this episode is your wake-up call.

What you’ll learn:

The most frequent audit findings related to risk grading
Real-world case studies showing where manufacturers got it wrong
A clear step-by-step guide to build a compliant and logical matrix
How to use ISO 14971 & ISO/TR 24971 correctly
Why severity should NEVER be downgraded after controls

We’ll also cover:

How to scale your matrix by device class
Common pitfalls to avoid
How to align QA, RA, clinical, and engineering teams
How Easy Medical Device can help you fix or build your Risk Management system

Whether you’re in Regulatory Affairs, Quality Assurance, R&D, or Clinical, this episode will give you concrete tools to strengthen your risk files and pass your audits with confidence.

Watch now and share it with your team!
Need help? Contact Easy Medical Device to review or improve your Risk Management File.

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Notified Bodies raise concern on Risk Grading appeared first on Medical Device made Easy Podcast. hamza benafqir

Software as a Medical Device: Beginner’s Guide to Testing & Validation

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 12 Jun 2025 00:00:00 +0000

Learn how to turn user needs into clear, beginner-friendly test plans for Software as a Medical Device (SaMD). In this episode, we break down the essentials of SaMD validation—no PhD required! We cover:

Why testing matters: Real-world examples of what can go wrong (and how to avoid it)

From user needs to test cases: Simple “if-then” steps you can try today

Who should test: Pros and cons of in-house vs. external testers

eQMS basics: How to validate your electronic Quality Management System with minimal hassle

Quick tips: The one thing you must do first, and the top beginner pitfall to avoid

Whether you’re a developer, QA engineer, or healthcare innovator, you’ll walk away with practical strategies to ensure your medical software is safe, reliable, and compliant. Tune in and make your next SaMD project a success!

Link

Anindya Mookerjea:  https://www.linkedin.com/in/anindyamookerjea
S-Cube Technologies: https://eqms-smarteye.com/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Software as a Medical Device: Beginner’s Guide to Testing & Validation appeared first on Medical Device made Easy Podcast. hamza benafqir

Medical Device News JUNE 2025 Regulatory Update

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Wed, 04 Jun 2025 23:15:44 +0000

Europe

Notified Body survey report – 31 October 2024 – What is the main Surprise: https://health.ec.europa.eu/document/download/59b9d90e-be42-4895-9f6f-bec35138bb0a_en?filename=md_nb_survey_certifications_applications_en.pdf
The MIR form has been updated – Version 7.3.1 – Don’t use previous versions: https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance/pmsv-reporting-forms_en

UK

UK MIR and FSCA – Change is in the AIR: https://www.gov.uk/government/publications/more-implementation/gb-mir-and-fsca-schema-implementation-guide
UK MDR 2002 is dying – Long life to UK MDR 2025: https://www.legislation.gov.uk/ukdsi/2025/9780348269529
: Real-World Data or Clinical Trial or Both?- This is the question: https://www.gov.uk/government/publications/mhra-guidance-on-the-use-of-real-world-data-in-clinical-studies-to-support-regulatory-decisions/mhra-guidance-on-the-use-of-real-world-data-in-clinical-studies-to-support-regulatory-decisions

Training

EU MDR Green Belt June 2025 – June 23rd, June 27th: https://school.easymedicaldevice.com/course/gb34/
eTraining on Vigilance and Audit preparation – Self-paced: https://school.easymedicaldevice.com/emd-course

ROW

USA

Q-Sub update – New electronic template: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/electronic-submission-template-medical-device-q-submissions

Brazil

SIUD or UDI in Brazil – Manual of Use in Portuguese: https://www.gov.br/anvisa/pt-br/assuntos/produtosparasaude/temas-em-destaque/arquivos/manual_siud_v01.pdf

Saudi Arabia

Series of Webinar – June is a Busy month in Saudi Arabia:
- 16 June 2025 Companion Diagnostic Regulatory Requirements: https://www.sfda.gov.sa/en/workshop/3540492
- 17 June 2025 Saudi Unique Device Identification (SAUDI-DI): https://www.sfda.gov.sa/en/workshop/3540493
- 19 June 2025 Artificial Intelligence and Machine Learning: https://www.sfda.gov.sa/en/workshop/3540495
- 23 June 2025 Digital Health Medical Devices regulatory approach: https://www.sfda.gov.sa/en/workshop/3540496
- 24 June 2025 Medical Devices Risk Classification: https://www.sfda.gov.sa/en/workshop/3540497
Saudi In-house Devices – Not like EU: https://www.sfda.gov.sa/sites/default/files/2025-05/MDS-G022En.pdf

Turkey

In Turkey, Economic Operators are Liable – Even after discontinuation or temporary stop of supply: https://titck.gov.tr/duyuru/tibbi-cihazlarin-tedarikinin-kesintiye-ugramasi-veya-durdurulmasi-sona-ermesi-durumunda-i-ktisadi-i-sletmecilerin-yukumlulukleri-hakkinda-duyuru-21052025113350

PODCAST

Podcast Nostalgia – What happened in May 2025
- Episode 334 – What is the new UK Post-Market Surveillance Requirements? With Claire Dyson: https://podcast.easymedicaldevice.com/334-2/
- Episode 335 – When is Regulatory Affairs needed during Design? With Aouda Ouzza: https://podcast.easymedicaldevice.com/335-2/
- Episode 336 – is EHDS dangerous for Medical Device Manufacturers? With Cecile van der Heijden: https://podcast.easymedicaldevice.com/336-2/
- Episode 337 – How Deepeye Medical overcame the AI Act? With Carmen Bellebna; https://podcast.easymedicaldevice.com/337-2/
- Episode 338 – Trapped or Strategic? Changing Notified Bodies During MDR transition: https://podcast.easymedicaldevice.com/338-2/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Medical Device News JUNE 2025 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

Trapped or Strategic? Changing Notified Bodies During MDR Transition

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Wed, 28 May 2025 23:24:39 +0000

Who is Monir El Azzouzi?

Links from the Video

Linkedin Post: https://www.linkedin.com/feed/update/urn:li:activity:7331974765156384769/
Team NB position paper transfer agreement: https://www.team-nb.org/wp-content/uploads/2025/01/Team-NB-PositionPaper-TransferAgreement-v02-20240702-with-instructions.pdf
MDCG 2022-4: https://health.ec.europa.eu/system/files/2022-12/mdcg_2022-4_en.pdf

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Trapped or Strategic? Changing Notified Bodies During MDR Transition appeared first on Medical Device made Easy Podcast. hamza benafqir

How deepeye Medical overcame the AI ACT?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 22 May 2025 00:00:00 +0000

In this episode, Carmen Bellebna will share with us the journey of deepeye Medical to implement the EU AI act requirements in parallel with the EU MDR certification. We will review first what is the AI ACT for those that are still not aware and also all the challenges that deepeye went through to be able to get the EU MDR certification.

Who is Carmen Bellebna?

Carmen Bellebna is a Regulatory Affairs and Quality Management expert at deepeye Medical, a medtech company pioneering AI-driven solutions for ophthalmology. With a strong background in implementing EU regulatory frameworks, Carmen has been closely following the evolution of the Artificial Intelligence Act (AI Act) and its intersection with the Medical Device Regulation (MDR). She has played a key role in integrating AI-specific compliance strategies into deepeye’s QMS, ensuring alignment with both MDR and upcoming AI requirements. Carmen recently delivered a well-received presentation at the Outsourcing in Clinical Trials (OCT) conference in Munich, where she shared hands-on insights and practical tips for operationalizing AIA obligations within a regulated medtech environment.

Who is Monir El Azzouzi?

Link

Carmen Bellebna LinkedIn:  https://www.linkedin.com/in/men-be-a1828a81/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/

The post How deepeye Medical overcame the AI ACT? appeared first on Medical Device made Easy Podcast. hamza benafqir

Is EHDS dangerous for Medical Device manufacturers?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 15 May 2025 00:00:00 +0000

In this episode, Cecile van der Heijden will disclose all the secret of the EHDS or European Health Data Space law. We will talk about the impact on Medical Device manufacturers but also on you as a human being as all this is about manipulation of data. Personal data or anonymized data. But can it be un-anonymized… Listen to this episode.

Who is Cecile van der Heijden?

Cécile van der Heijden is a senior legal expert at Axon Lawyers, a boutique law firm based in the Netherlands specialized in legal and regulatory affairs for the life sciences sector. With a strong focus on digital health, data protection, and medical device law, Cécile advises companies on navigating complex European regulations such as the MDR, GDPR, and the newly adopted European Health Data Space (EHDS) Regulation. She regularly supports clients developing AI, software as a medical device (SaMD), and connected technologies, helping them align innovation with compliance. Known for her practical approach, Cécile frequently speaks at conferences and publishes insights on digital health law across the EU.

Who is Monir El Azzouzi?

Link

Cecile van der Heijden LinkedIn Profile: https://www.linkedin.com/in/cevanderheijden/
Axon Lawyers website: https://www.axonlawyers.com/
EHDS: https://www.european-health-data-space.com/
Article EHDS: https://www.consilium.europa.eu/en/press/press-releases/2025/01/21/european-health-data-space-council-adopts-new-regulation-improving-cross-border-access-to-eu-health-data/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/

The post Is EHDS dangerous for Medical Device manufacturers? appeared first on Medical Device made Easy Podcast. hamza benafqir

When is Regulatory Affairs needed during Design?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Wed, 07 May 2025 23:33:32 +0000

In this episode, Aouda Ouzza is helping us understand when the Regulatory Affairs person is needed during the design phase. The problem that we will uncover here is the fact that in most cases the design team are calling the Regulatory Affairs person on a project when they have finished everything and they need this person to take care of the registration before launch. But this is wrong, and we’ll let you know when and why you should involve them earlier. Listen to this episode.

Who is Aouda Ouzzaa?

Aouda Ouzzaa brings over 16 years of expertise in Regulatory Affairs (RA) and Quality Assurance (QA), supporting the entire product lifecycle—from development to post-market surveillance. She has successfully led projects across pharmaceuticals, biologics, medical devices (EU MDR), cosmetics, and Software as a Medical Device (SaMD).

Her global regulatory knowledge spans EMA, FDA, GCC, and Rest of World (ROW) markets. Aouda has hands-on experience preparing IND, BLA submissions, and securing orphan drug designations.

As a certified GMP and GDP auditor, Aouda has worked closely with cross-functional teams to ensure compliance with international standards while optimizing regulatory interactions. Her methodical approach and deep understanding of complex regulatory environments make her a strategic asset for organizations navigating global compliance challenges.

Whether you’re developing a new drug, launching a medical device, or scaling a digital health solution, Aouda Ouzzaa brings the insight and precision needed to achieve regulatory success.

Who is Monir El Azzouzi?

Link

Aouda Ouzza LinkedIn Profile: linkedin.com/in/aouda-ouzzaa-51877a32
SmartQARA website: https://smartqara.com/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/

The post When is Regulatory Affairs needed during Design? appeared first on Medical Device made Easy Podcast. hamza benafqir

What is the new UK Post-Market Surveillance Requirements?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 01 May 2025 00:00:00 +0000

In this episode, Claire Dyson will clarify to us what is the new PMS requirements from UK MHRA. You have maybe heard recently the UK MHRA saying that there should be a new requirement to perform Post-Marketing Surveillance for Medical Devices in the UK. So what this means? Who is impacted? How to comply? Listen to this episode.

Who is Claire Dyson?

Claire Dyson began her career in rational drug design and moved into medical device through devices that interact with drugs and drug-delivery systems. Claire entered certification bodies in 2018 and is now the Head of UK Approved Body for DQS, an international, accredited certification body offering ISO 13485, MDSAP and CE conformity assessment to medical device manufacturers. She is involved in DQS’s application to become a UK Approved Body and offer UKCA conformity assessment. In parallel, she interacts with DQS’s international team developing accessible content to support manufacturers with the regulatory pathways and transitions.

Who is Monir El Azzouzi?

Links from the Video

Claire Dyson LinkedIn:  Claire Dyson | LinkedIn
Blogs – 3 part series on U vs UK PMS
UK PMS Regulations: Overview & Key Requirements for Medical Device Safety
UK Medical Device Vigilance – Part 2: Vigilance & Reporting Requirements
UK PMS vs EU MDR – Key Differences & Impact on CE-Marked Medical Devices

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/

The post What is the new UK Post-Market Surveillance Requirements? appeared first on Medical Device made Easy Podcast. hamza benafqir

How to register your Medical Device in Malaysia?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 24 Apr 2025 00:00:00 +0000

In this episode, Adam Isaacs Rae is helping us to register our Medical Devices in Malaysia. We will review the requirements for it. You will see in this episode that some elements will be similar to registration in EU or US but you will also see a lot of differences. We will also talk about cost for the registration and you will see how this is affordable.

Who is Adam Isaacs Rae?

Chartered quality professional with a Master’s Degree focused in Strategic Quality Management from University of Portsmouth. Demonstrated history of working aerospace & defence, medical device and the construction industry. Skilled in Operations Management, Lean Six Sigma, Failure Mode and Effects Analysis (FMEA), Value Stream Mapping and Supply Chain Management.

Who is Monir El Azzouzi?

Link

Adam Isaacs Rae LinkedIn:  https://www.linkedin.com/in/adam-isaacs-rae/
https://theotherconsultants.substack.com/p/register-your-medical-device-in-malaysia

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post How to register your Medical Device in Malaysia? appeared first on Medical Device made Easy Podcast. hamza benafqir

Should you quit your job to become a consultant?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Wed, 16 Apr 2025 23:31:09 +0000

In this episode, Yassine Bader will explain to you the advantage or the risk of quitting your permanent job to become a consultant. You will see within this episode that this is not something made for everyone, so you really need to listen to this to understand if this is the right decision for you.

Who is Yassine Bader?

Coach expert en transition de carrière et leadership, Yassine Bader cumule plus de 15 ans d’expérience au cœur de l’industrie (automobile, chimique, dispositifs médicaux, transport, pharmaceutique et agroalimentaire), accompagnant avec succès plus de 100 cadres vers une indépendance entrepreneuriale inspirante et un leadership d’excellence. Son approche : pragmatique, percutante, tournée vers l’action et les résultats concrets. Créateur du guide gratuit et fondateur du programme ManagerImpact, il équipe les managers d’outils précis et immédiatement exploitables pour devenir des leaders alignés, confiants et reconnus. Très prochainement, il dévoilera un séminaire exclusif destiné aux cadres industriels décidés à franchir le pas vers le consulting et le management de transition freelance, en leur fournissant toutes les clés indispensables pour réussir avec confiance leur nouvelle vie professionnelle.

Who is Monir El Azzouzi?

Link

Yassine Bader LinkedIn: https://www.linkedin.com/in/yassine-bader-yab/
Programme Yassinebader: https://programme.yassinebader.com/manager-impact

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Should you quit your job to become a consultant? appeared first on Medical Device made Easy Podcast. hamza benafqir

How to satisfy Cybersecurity for FDA and EU?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 10 Apr 2025 12:00:00 +0000

In this episode, Cyrille Michaud from MD101 will explain us how to prepare for Cybersecurity compliance for your medical device. We will review the US and EU requirements and provide you a list of legislation and standards you should look at. Cyrille will also share his experience related to the reviews done by a Notified Body and an FDA.

Who is Cyrille Michaud?

Co-founder and managing partner of MD101 Consulting.
Consultant in Quality Assurance and Regulatory Affairs for software in medical devices and software as medical devices.

Specialties: Software Processes Management.
CE Mark & FDA 510k
21 CFR 820 – ISO 13485 – ISO 14971 – IEC 62304 – IEC 62366 – IEC 60601 – IEC 82304-1 – UL 2900-1 – IEC 81001-5-1
Agile Methods applied to medical device software design.
Cybersecurity applied to medical devices.

Who is Monir El Azzouzi?

Link

Cyrille Michaud LinkedIn:  https://www.linkedin.com/in/cyrillemichaud/
MD101 : www.MD101.io
Trainings on Cybersecurity : https://blog.cm-dm.com/pages/Medical-Device-Software-Trainings
Blog post sur cyber et normes : https://blog.cm-dm.com/post/2023/10/06/Final-2023-FDA-Premarket-Cybersecurity-guidance-released
FDA resources on cybersecurity : https://www.fda.gov/medical-devices/digital-health-center-excellence/cybersecurity
IG NB checklists : https://www.ig-nb.de/veroeffentlichungen (page in German but download links in the page are in English)
Standard IEC 81001-5-1 and 81001-5-2: https://blog.cm-dm.com/post/2024/10/04/IEC-81001-5-2%3A-AAMI-SW96-cousin-and-IEC-80001-5-1-sister
Blog IEC 81001-5-1: https://blog.cm-dm.com/post/2024/02/23/IEC-81001-5-1-Right-Here-Right-Now

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post How to satisfy Cybersecurity for FDA and EU? appeared first on Medical Device made Easy Podcast. hamza benafqir

Medical Device News April 2025 Regulatory Update

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Fri, 04 Apr 2025 00:00:00 +0000

Sponsor: Medboard

Europe

Certificates under Condition – Team NB press release: https://www.team-nb.org/wp-content/uploads/2025/03/PressRelease-WP3-Task3.3-Certificates-with-Conditions-20250312.pdf
European Artificial Intelligence Office -A new expert panel for AI Medical Devices: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202500454

UK invented the AIaMD – Fewer law but more guidance: https://www.gov.uk/government/publications/the-regulation-of-artificial-intelligence-as-a-medical-device-government-response-to-the-rhc/the-regulation-of-artificial-intelligence-as-a-medical-device-government-response-to-the-regulatory-horizons-council
Submit a Clinical Study in Spain and Belgium – Each country decides:
- Spain: https://www.aemps.gob.es/informa/la-aemps-detalla-el-procedimiento-para-la-publicacion-de-informes-de-investigaciones-clinicas-con-productos-sanitarios-en-espana/
- Belgium: https://www.afmps.be/sites/default/files/Guideline%20Submission%20of%20Clinical%20Investigation%20according%20to%20MDR_version%2011.0_0.pdf
SCHEER – Brain Stimulators – Non-medical purpose use: https://health.ec.europa.eu/latest-updates/scheer-minutes-working-group-meeting-brain-stimulators-19-march-2025-2025-03-28_en
IMDRF Reliance Program – For Regulators but can impact manufacturers: https://www.imdrf.org/sites/default/files/2025-03/IMDRF%20Reliance%20playbook%20draft%20%28final%29.pdf
Successful Pilot Advice Expert Panel – For high-risk device: https://www.ema.europa.eu/en/documents/report/pilot-advice-expert-panels-manufacturers-high-risk-medical-devices-interim-report-experience-pilot-february-2023-december-2024_en.pdf
Team NB MDR Clinical Training – May 7th 2025: https://www.team-nb.org/wp-content/uploads/2025/03/Leaflet-MDR-Clinical-Manufacturers-Training-20250507.pdf

Registration

Ask Easy Medical Device for Registration – Support most of the world: https://easymedicaldevice.com

ROW

Sex Specific Data in Clinical Study – Do it or?: https://www.fda.gov/media/82005/download
Brazil UDI in Progress – Subtitle: Anvisa consultation is open: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2025/anvisa-abre-consulta-publica-sobre-base-de-dados-para-identificacao-unica-de-dispositivos-medicos
Become a Conformity Assessment Body in Malaysia – Notified Body are not automatically Conformity assessment bodies: https://www.mda.gov.my/images/DOC%20UPLOAD/DOC%20UPLOAD%202025/Guidance%20Document%20Conformity%20Assessment%20Body%20CAB%20Guide%20for%20Conducting%20Conformity%20Assessment%20By%20Way%20of%20Verification.pdf
Saudi Arabia ISO 13485 guidance -Looks like an MDSAP structure: https://www.sfda.gov.sa/sites/default/files/2025-03/MDS-G024.pdf
Singapore Cybersecurity Best Practice – Consultation until May 12, 2025: https://www.hsa.gov.sg/docs/default-source/hprg-mdb/regulatory-updates/best-practices-guide-on-medical-device-cybersecurity_draft-for-consultation.pdf?sfvrsn=8dcfa560_1

Podcast

Episode 328 – What are the TOP 3 FDA inspection issues with Darrin Carlson: https://podcast.easymedicaldevice.com/328-2/
Episode 329 – What if the Notified Body asks you: Is your Software Validated?: https://podcast.easymedicaldevice.com/329-2/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Medical Device News April 2025 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

What if the Notified Body asks you: Is your Software Validated?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 27 Mar 2025 00:00:00 +0000

In this episode, Tibor Zechmeister will challenge us on what we would answer if the Notified Body asks if our software is validated. CSV or Computer System Validation will become one of the major topics So stay tuned.

Who is Tibor Zechmeister?

Passionate about Creating Maximum Efficiency in MedTech Regulatory | Head of Regulatory and Quality Flinn.ai | Notified Body Auditor | MedTech Entrepreneur | Software Solutions for Regulatory Automation with AI

Who is Monir El Azzouzi?

Link

Tibor Zechmeister LinkedIn:  https://www.linkedin.com/in/tibor-zechmeister/
Flinn.ai Website: https://www.flinn.ai/
ISO 13485:2016 https://www.iso.org/standard/59752.html
ISO/TR 80002-2:2017: https://www.iso.org/standard/60044.html

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post What if the Notified Body asks you: Is your Software Validated? appeared first on Medical Device made Easy Podcast. hamza benafqir

What are the TOP 3 FDA inspection issues?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 20 Mar 2025 04:59:54 +0000

In this episode, Darrin Carlson will explain to us what are the main issues that are discovered during FDA inspections and how to correct them. We will also explain the different between an FDA inspection and a Notified Body audit. So stay tuned.

Who is Darrin Carlson?

Darrin Carlson has over ten years of experience in Quality and Regulatory in the medical device, pharmaceutical, and combination product fields. In addition to his current role as a Regulatory Affairs Specialist, he also helps small MedTech companies stay compliant with AI-powered, human-driven internal audits and publishes the QA/RA Playbook, a free weekly newsletter helping subscribers simplify compliance, empower innovation, and advance their careers.

Who is Monir El Azzouzi?

Link

Darrin Carlson LinkedIn:  https://www.linkedin.com/in/darrinlcarlson/
Fix the Top 6 QMS Issues: https://qarasolutions.com/fixthetopsix
FDA page on Warning Letters: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters
FDA page on 483 data: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/inspection-observations

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post What are the TOP 3 FDA inspection issues? appeared first on Medical Device made Easy Podcast. hamza benafqir

Medical Device News March 2025 Regulatory Update

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 13 Mar 2025 02:05:38 +0000

Sponsor

Medboard: https://www.medboard.com/

Europe

Health Data Legislation – Manufacturers should comply: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202500327&qid=1741166600030
- FAQ: https://health.ec.europa.eu/document/download/4dd47ec2-71dd-49fc-b036-ad7c14f6ed68_en?filename=ehealth_ehds_qa_en.pdf
eIFU proposal until March 21st- eIFU for professional user: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14470-Medical-devices-electronic-instructions-for-use_en
14th Notified Body Under IVDR – Centro Nacional de Certification de Productos Sanitarios: https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/notifications?organizationRefeCd=EPOS_43640&filter=notificationStatusId:1
Exceptional access of Non-CE Medical Devices – France simplified form: https://ansm.sante.fr/actualites/acces-derogatoire-pour-un-dispositif-medical-depourvu-de-marquage-ce-optimisation-du-processus-de-demande-a-lansm
EMA scientific Advice for High-risk device – Portal available: https://www.ema.europa.eu/en/news/ema-establishes-regular-procedure-scientific-advice-certain-high-risk-medical-devices
- Guide: https://www.ema.europa.eu/en/documents/other/guide-manufacturers-procedure-requesting-advice-expert-panels-clinical-investigations-or-clinical-development-strategies-high-risk-medical-devices_en.pdf
IGJ on Generative AI in Healthcare – Be careful: https://www.igj.nl/zorgsectoren/medische-technologie/publicaties/publicaties/2025/02/10/igj-roept-zorgaanbieders-op-ga-zorgvuldig-om-met-invoering-van-generatieve-ai-toepassingen
Pilot for Clinical Investigation and Performance Study – 1 application for all member states: https://health.ec.europa.eu/medical-devices-clinical-investigations-and-performance-studies/pilot-coordinated-assessment-cips_en
- FAQ: https://health.ec.europa.eu/document/download/7ee00635-08dd-4c24-b892-74fc8eebfb54_en?filename=md_ci_pilot-ci-ps_faq_0.pdf
- Participating member states: https://health.ec.europa.eu/document/download/e987dcf9-cc8c-44c4-b772-18919cd3f84c_en?filename=md_ci_pilot-ci-ps_ms-pilot-coordinated-assessment.pdf
What is an AI system – Read the guide: https://digital-strategy.ec.europa.eu/en/library/commission-publishes-guidelines-ai-system-definition-facilitate-first-ai-acts-rules-application

Switzerland

Swissmedic assessment on PMS – Result is BAD: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/market-surveillance-of-medical-devices/schwerpunktaktionen/ueberpruefung-dokumentation-ueberwachung-nach-inverkehrbringen-smc.html

UK

IVD registration in the UK – Transition to IVDR: https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market
- EU IVDD Extension: https://www.gov.uk/government/publications/registration-of-in-vitro-diagnostic-devices-with-expiring-ce-certificates/registration-of-certain-in-vitro-diagnostic-devices
Reliance on Exention of CE- Reusable Class I devices : https://www.gov.uk/government/publications/registration-of-reusable-or-upclassified-class-i-devices-andor-expiring-ce-certificates/registration-of-certain-medical-devices-which-are-reusable-class-i-devices-upclassified-class-i-devices-andor-reliant-on-expiredexpiring-ce-certif#reliance-on-extended-certificates-in-great-britain-gb–

Webinar

28 March – AI in Healthcare – EU priorities and Ecosystem Synergies: https://digital-strategy.ec.europa.eu/en/events/ai-healthcare-eu-priorities-and-ecosystem-synergies

Easy Medical Device Newsletter – Get fresh information: https://www.linkedin.com/posts/easymedicaldevice_medicaldevices-mdr-regulatorycompliance-activity-7304455925044531200-mKt0?utm_source=share&utm_medium=member_desktop&rcm=ACoAAABZ07ABDocaBMTLJo8bsl8V3bgNSBIiZuI
Medtech Leading Voice Newsletter – Reference a lot of Medical Device posts: https://www.linkedin.com/newsletters/medtech-leading-voice-6871913764770324480/

ROW

Australia: Ask consent if product not compliant – Not compliant to the Essential Principles: https://www.tga.gov.au/resources/resource/reference-material/consent-medical-devices-do-not-meet-essential-principles
South Africa: Classification rules – Some rules were updated: https://www.sahpra.org.za/wp-content/uploads/2022/01/SAHPGL-MD-04_v5-Guideline-for-Classification-of-MD-and-IVDs.pdf
Application to Canada – Draft guidance: https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/medical-devices/application-information/guidance-documents/managing-applications-licenses/draft-guidance-on-managing-applications-for-medical-device-licences-eng.pdf

Podcast

Episode 323 – The good, the bad and the ugly of certification bodies with Mark Rogovoi; https://podcast.easymedicaldevice.com/323-2/
Episode 324 – How and who to build your Risk Management File with Bijan Elahi: https://podcast.easymedicaldevice.com/324-2/
Episode 325 – FDA: Advantage of the Breakthrough Device Program with Michelle Lott: https://podcast.easymedicaldevice.com/325-2/
Episode 326 – How to avoid Clinical Investigation for your Device with Hatem Rabeh: https://podcast.easymedicaldevice.com/326-2/

The post Medical Device News March 2025 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

How to avoid Clinical Investigation for your Device?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 06 Mar 2025 02:02:21 +0000

In this episode, Hatem Rabeh will explain to us what are Clinical Data and also if there is a chance for you to avoid Clinical Investigations. There are also some confusion between Clinical Evaluation and Clinical Investigation. Let’s clarify all this and give you the right strategies for your Medical Devices. So stay tuned.

Who is Hatem Rabeh?

Hatem Rabeh is a Medical Doctor with an MSc in Medical Engineering, specializing in clinical evaluation for medical devices.

With over 8 years of experience, he supports manufacturers in MDR compliance by preparing Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER) for Class I to Class III devices, including software, implants, and robotic systems. His expertise covers literature reviews, clinical strategy, and regulatory compliance.

Hatem also shares his knowledge through online training, consulting, and LinkedIn content.

Who is Monir El Azzouzi?

Link

Hatem Rabeh LinkedIn: https://www.linkedin.com/in/hatem-rabeh/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post How to avoid Clinical Investigation for your Device? appeared first on Medical Device made Easy Podcast. hamza benafqir

FDA: Advantage of the Breakthrough Device Program

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 27 Feb 2025 00:00:00 +0000

In this episode, Michelle Lott will walk us through the Breakthrough Device Program created by the FDA. Who can benefit from it? And what are the benefits? Michelle will explain if you can be part of this and how to do it also. So stay tuned.

Who is Michelle Lott?

Michelle Lott is the founder and principal of leanRAQA, which has supported 100+ companies with regulatory strategy, regulatory submissions, quality systems compliance, FDA audits, due diligence, technical support services – (and grief counseling, because dealing with regulators can be emotionally draining!). She has served on the FDA Device Good Manufacturing Practices Advisory Committee and is a vocal advocate of EU MDR readiness. Michelle serves the medical device, dietary supplements, biologics, pharmaceutical, cosmetics, and food industries. She has a weakness for tequila and anything barbecued.

Who is Monir El Azzouzi?

Link

Michelle Lott LinkedIn: https://www.linkedin.com/in/michellelottraqa/
Company page : https://leanraqa.com/
FDA breakthrough devices program guidances: https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post FDA: Advantage of the Breakthrough Device Program appeared first on Medical Device made Easy Podcast. hamza benafqir

How and Who to build your Risk Management File?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 20 Feb 2025 00:27:00 +0000

In this episode, Bijan Elahi will share with us the methodology you should follow to start your Risk Management Project. On some of my consulting projects, I ask people if they can send me their Risk Management File, which usually follows by “I don’t have one” and then by “How can we create one?”. So Today Bijan Elahi who is an expert on risk management will explain the best way to start such project.

Who is Bijan Elahi?

Bijan Elahi has worked in risk management for medical devices for over 30 years at the largest medical device companies in the world, as well as small startups. He is a Technical Fellow, and an affiliate professor at Drexel University. Previously he served as the Medtronic corporate Advisor on safety risk management of medical devices. Bijan is a lecturer at Eindhoven University of Technology (Netherlands), where he teaches risk management to doctoral students in engineering. At the invitation of the FDA, he teaches a graduate course on medical device risk management at Drexel University (Philadelphia, USA).

Bijan Elahi is the founder of MedTech Safety, Inc., an education and advisory company. He has educated over 10,000 individuals worldwide with outstanding results. Bijan is a frequently invited speaker at international professional conferences, and is also a contributor to ISO 14971, the international standard on the application of risk management to medical devices. He is the author of the best-selling medical book: Safety Risk Management for Medical Devices, published by Elsevier publishing.

Who is Monir El Azzouzi?

Link

Linkedin Page: https://www.linkedin.com/in/bijanelahi/
Medtech Safety website: https://www.medtechsafety.com/
Safety Risk Management for Medical Devices Book: https://www.amazon.com/Safety-Risk-Management-Medical-Devices-ebook/dp/B09M3QXNL9/ref
Conference website: https://medsafetyconf.net/home.php
Conference registration page (early bird discounts end on 28 February): https://medsafetyconf.net/registreren.php
Bijan’s email: bijan@medtechsafety.com

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post How and Who to build your Risk Management File? appeared first on Medical Device made Easy Podcast. hamza benafqir

The good, the bad and the ugly of certification bodies

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 13 Feb 2025 00:00:00 +0000

In this episode, Mark Rogovoi will share his experience with Certification bodies. He had the experience working for them and working for manufacturers so this is really something that can show you the inside. You will see the good of working with them but also the bad. Mark will be really honest and share some stories, and you’ll see that this is not all good.

Who is Mark Rogovoi?

Mark Rogovoi brings 18 years of international experience in Manufacturing Quality across Poland, Russia, Kazakhstan, Spain, and Israel. He is a seasoned QMS professional proficient in ISO 9001 and ISO TS 16949 standards, with a strong Lean 6 Sigma background as a certified Green Belt. As a Lead Auditor for ISO 9001, he has conducted both internal and external audits. Mark also holds an EMBA from the Stockholm School of Economics and a master’s degree in Electrotechnical Engineering from Saint-Petersburg State Electrotechnical University.

Who is Monir El Azzouzi?

Link

Mark Rogovoi LinkedIn: https://www.linkedin.com/in/markrogovoi/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post The good, the bad and the ugly of certification bodies appeared first on Medical Device made Easy Podcast. hamza benafqir

Medical Device News January 2025 Regulatory Update

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 06 Feb 2025 02:09:38 +0000

Medboard

EU MDR and IVDR article 10a – Discontinuation of Supply: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0745-20250110#art_10a
EU IVDR transition periods – Visual: https://health.ec.europa.eu/document/download/ff7fa114-c539-46b3-9066-4bfbb306e9de_en?filename=timeline_ivdr_en.pdf
EUDAMED
EMDN: UPDATE or not to UPDATE – MDCG 2024-2 Rev 1 and 2021-12 Rev 1 :
Contact points of National Authorities – Bookmark them in case: https://health.ec.europa.eu/document/download/c28e965a-3b7c-4a5b-a6ee-d1724d06f20d_en?filename=md_contact_points_of_national_authorities.pdf
EU Battery 2023/1542 – Guidance issued by EU commission: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:C_202500214
Swiss Maintenance of Medical Devices – Guidance for Hospitals: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/reprocessing—maintenance/maintenance.html
UK timeline for UKCA – Be ready for 2030: https://assets.publishing.service.gov.uk/media/6718b88738149ce9d09e3894/Infographic_-_Devices_transition_timeline.pdf
UK Post-Market Surveillance – Implementation and Template of PSUR: https://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements/the-medical-devices-post-market-surveillance-requirements-amendment-great-britain-regulations-2024-guidance-on-implementation
TUK Vigilance Reporting – Field Safety notices and Example of incidents: https://www.gov.uk/government/publications/medical-devices-examples-of-reportable-incidents
- FSN: https://www.gov.uk/guidance/effective-field-safety-notices-fsns-guidance-for-manufacturers-of-medical-devices#full-publication-update-history
- Devices for cardiac ablation: https://www.gov.uk/government/publications/reporting-adverse-incidents-devices-for-cardiac-ablation
- Joint Replacement implant: https://www.gov.uk/government/publications/reporting-adverse-incidents-joint-replacement-implants#full-publication-update-history
- Intraocular lenses: https://www.gov.uk/government/publications/reporting-adverse-incidents-intraocular-lenses
- Insulin pumps and meter systems: https://www.gov.uk/government/publications/reporting-adverse-incidents-insulin-pumps-and-meter-systems
UK guide for IVD – Learn before to re-learn: https://assets.publishing.service.gov.uk/media/67863a313ef063b15dca0f47/Guidance_on_the_regulation_of_IVD_medical_devices_in_GB.pdf

Training

EU MDR training – Green Belt Certification Program: https://school.easymedicaldevice.com/course/gb33/

Rest of the World:

Laboaratory Developed Tests FAQ – Learn all about LDTs: https://www.fda.gov/medical-devices/laboratory-developed-tests-faqs/definitions-and-general-oversight-laboratory-developed-tests-faqs and https://www.fda.gov/medical-devices/laboratory-developed-tests-faqs/medical-device-reporting-complaints-and-corrections-removals-reporting-laboratory-developed-tests
How to apply your dossier in Australia – Full guidance by TGA: https://www.tga.gov.au/how-we-regulate/manufacturing/manufacture-medical-device/obtain-and-maintain-regulatory-evidence/australian-regulatory-evidence-options-medical-device-application/tga-conformity-assessment-certification/application-instructions-conformity-assessment
Malaysia guidance for HIV Self-test – Placement on the Malaysia Market: https://www.mda.gov.my/index.php/documents/ukk/3480-final-gd-placement-of-hiv-self-test-kit-in-malaysia-market-2nd-edition-pdf/file
Import Medical Device for Personnal Use in Malaysia – What means Personal use? https://portal.mda.gov.my/index.php/documents/ukk/3468-draft-public-comment-gd-importation-of-medical-device-for-personal-use-second-edition-updated-2025-pdf/file
Alert by Philippines for Product registration – Engaging consultants is not encouraged: https://www.fda.gov.ph/wp-content/uploads/2025/01/FDA-Advisory-No.2025-0033-.pdf
Saudi Arabia clearance of Medical Devices – For trainings or conferences: https://www.sfda.gov.sa/sites/default/files/2025-01/Guide%20to%20Conditions%20and%20requirements%20for%20Clearing%20food%2C%20Medical%20devices%2C%20and%20cosmetics%20for%20exhibitions%2C_1.pdf
China Medical Device Regulations Round-up 2024 – Cisema.com video: 2024 Round-Up of China Medical Device regulations
India update classification lists – List available: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTIzNDI=

Podcast

Episode 318 – How to register a Medical Device in South Africa – Khanysile Nkuku : https://podcast.easymedicaldevice.com/318-2/
Episode 319 – How to perform your PMS for a Drug-Device Combination – Joan D’Souza: https://podcast.easymedicaldevice.com/319-2/
Episode 320 – Top 5 common NCs on an ISO 13485 audit: https://podcast.easymedicaldevice.com/320-2/
Episode 321 – 6 Tips to grow as a QA RA Manager: https://podcast.easymedicaldevice.com/321-2/

The post Medical Device News January 2025 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

6 Tips to Grow as a QA RA Manager

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 30 Jan 2025 02:06:00 +0000

In this episode, I will give you 6 tips to help you grow as a QA RA Manager. These are coming from my own experience so maybe they are not exactly reflecting your situation but this may help you understand some logic.

Who is Monir El Azzouzi?

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post 6 Tips to Grow as a QA RA Manager appeared first on Medical Device made Easy Podcast. hamza benafqir

TOP 5 common NCs on an ISO 13485 audit

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 23 Jan 2025 00:57:48 +0000

In this episode, Adam Isaac Rae will share with us is TOP 5 common NCs during an ISO 13485 audit. He will go through all the clauses and for each of them he will bring his TOP issue. So after that the exercise will be for you to check if this issue can be identified within your QMS. So good research to you.

Who is Adam Isaacs Rae?

Who is Monir El Azzouzi?

Link

Adam Isaacs Rae LinkedIn:  https://www.linkedin.com/in/adam-isaacs-rae/
Top ISO 13485 Nonconformances: https://easymedicaldevice.com/top-iso-13485-nonconformances-and-how-to-prevent-them/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post TOP 5 common NCs on an ISO 13485 audit appeared first on Medical Device made Easy Podcast. hamza benafqir

How to perform your PMS for a Drug-Device Combination?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 16 Jan 2025 00:00:00 +0000

In this episode, Joan D’Souza will help us to do our PMS the right way when we have to deal with a Drug-Device Combination. We will review what is a Drug-Device Combination or DDC and then identify some case studies. She will also provide us with the guidances that we should follow.

Who is Joan D’Souza?

I have experience in pharmacovigilance, regulatory affairs, medical writing, and law (JD, licensed to practice law in the state of Minnesota, US). I offer future employers dedication, a passion for learning, and a longstanding insight into the pharmaceutical sector.

I am driven, hard-working, enthusiastic, and always willing to take on new responsibilities.

Therapeutic areas: vaccines, endocrinology, immunology, rare diseases, gastroenterology, autoimmune diseases, cardiovascular diseases, dermatology, medical devices, drug-device combinations, oncology, and neurology.

Who is Monir El Azzouzi?

Link

Joana de Souza LinkedIn:  https://www.linkedin.com/in/drjoanswatidsouza/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post How to perform your PMS for a Drug-Device Combination? appeared first on Medical Device made Easy Podcast. hamza benafqir

How to register a Medical Device in South Africa?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 09 Jan 2025 00:00:00 +0000

In this episode, Khanyisile Nkuku will share with us the way companies can register an medical device in South Africa today and also what change will happen in a near future. She will also talk to us about the participation of South Africa to the AMDF – Africa Medical Device Forum, where pilot project started to issue a continental approval within 22 countries. So this may help register more easily in Africa.

Who is Khanyisile Nkuku?

Ms Khanyisile Nkuku In her current role as a Medical device & IVD Registration Officer at the South Africa Competent Authority (SAHPRA) , she contributes her expertise in the assessment and registration of medical devices & IVD’s in South Africa to promote medical device & IVD access on a global scale, with a particular focus on African countries.

She holds a Bachelor of Pharmacy honours degree ,a Master’s in Pharmacy administration & Policy Regulation , and is currently busy with Masters in Business Administration in Healthcare Leadership .

She is an experienced Pharmacist with successful background in medical device & IVD regulations and regulatory system strengthening. Having great strength in policy advocacy, policy development, policy implementation and compliance.

She partakes in the International medical device regulatory forum (IMDRF) working groups and Africa medical device forum (AMDF) technical mainly the MDA-TC ( Medical device Assessment Technical committee member. She is further a committee member for two South African Bureau of Standards (SABS) Technical committees .

Who is Monir El Azzouzi?

Link

Khanyisile Nkuku LinkedIn:  http://linkedin.com/in/khanyisile-nkuku-975663a9
SAHPRA Website: https://www.sahpra.org.za/medical-devices/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post How to register a Medical Device in South Africa? appeared first on Medical Device made Easy Podcast. hamza benafqir

Medica: AI & MDR FLIP THE COIN

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 02 Jan 2025 00:00:00 +0000

Stefan bolleininger will share with us information regarding Artificial intelligence and MDR.

This presentation happened during Medica 2024. So if you have any questions you can ask ok the comments.

Who is Stefan Bolleininger?

Stefan Bolleininger is a key opinion leader and speaker for the medical device regulation MDR in Europe. He founded the be-on-Quality GmbH consulting agency to passionately support manufacturers during CE approvals or FDA approvals. This support covers the full chain of quality and regulatory requirements: Implementation, maintenance, audits, assessments, and inspections. In the area of “Risk Management and Usability for Medical Devices and Medical Networks”, he holds a teaching assignment at the Technical University of Nuremberg and the VDI Technical Committee “Quality Assurance for Software in Medical Devices”.

Link:

Stefan bolleininger LinkedIn: https://www.linkedin.com/in/stefan-bolleininger-3a717028/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Medica: AI & MDR FLIP THE COIN appeared first on Medical Device made Easy Podcast. hamza benafqir

Easy Medical Device Great Summary 2024

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 26 Dec 2024 00:00:00 +0000

In this episode, Monir El Azzouzi will summarize 2024 for Easy Medical Device and share projects for 2025. He will explain the situation in Consulting, Representation, eQMS , eIFU project, Medtech Conferences, Podcasts Episodes, Topra Awards and all the future projects in 2025.

Who is Monir El Azzouzi?

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Easy Medical Device Great Summary 2024 appeared first on Medical Device made Easy Podcast. hamza benafqir

What are the major pitfalls of Startups in Medical Devices?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 19 Dec 2024 00:00:00 +0000

In this episode, Adnan Ashfaq will share with us the major pitfalls he experienced when dealing with Medical Device startups. He will provide his advice so you can be successful and already know some issues that you may encounter as a Startup

Who is Adnan Asfaq?

Adnan Ashfaq is a Quality, Regulatory & Validation Specialist with almost 20 years of experience in Medical Device, Biotech, and Pharmaceutical industries. Adnan founded Pharmi Med in 2011 and has since been supporting Medical device companies around the labyrinth of regulations and assisting them in flying through successful audits. He has been working with start-up companies and multinationals in developing new products since 1999. With regulations tightening up, especially in Europe, Pharmi Med is enabling and trying to help simplify the compliance conundrum to ensure manufacturers reach their desired market and stay in the market.

Who is Monir El Azzouzi?

Link:

Adnan Ashfaq LinkedIn: https://www.linkedin.com/in/adnan-ashfaq-44478121/
Simplimedica website: https://simplimedica.com

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post What are the major pitfalls of Startups in Medical Devices? appeared first on Medical Device made Easy Podcast. hamza benafqir

Medical Device News December 2024 Regulatory Update

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 12 Dec 2024 00:00:00 +0000

MEDBOARD: https://www.medboard.com/

EUROPE

TEAM-NB high level position – Making Medical Devices Safer and Faster: https://www.team-nb.org/wp-content/uploads/2024/12/Team-NB-HighLevel-Strategy- PositionPaper-20241130.pdf
MDCG 2024-15 – Reporting Medical Device Trials Made Easy!: https://health.ec.europa.eu/document/download/0e076d19-62dc-4ff9-83f2-be6072a45993_en? filename=mdcg_2024-15_en.pdf
EMA activities on Combination products – Reminder on Drug-Device assessment.: https://www.ema.europa.eu/en/documents/presentation/presentation-sme-info-day- session-4-ema-activities-medical-devices_en.pdf

MDCG 2024-16 Interruption or Discontinuation – For certain devices: https://health.ec.europa.eu/document/download/b431b10f-8512-4f47-9191-e1b84b2f9a27_en? filename=mdr_qna-article10a_mdr-ivdr_en.pdf and annex https://health.ec.europa.eu/document/download/b4a7dea7-ae73-4e13-a8a8-11dcd2678d38_en?filename=md_mdc-2024-16 _annex_en.pdf
Joint Paper from 9 Member states – Council of the European Union: https://data.consilium.europa.eu/doc/document/ST-15380-2024-INIT/en/pdf
- Reduction of Administrative Burdens
- Centralization of System Management to the EMA
- Predictable Certification Procedures
- Enhanced Coordination and Support
- Impact Assessment and Resource Allocation
MDCG 2024-14 Master UDI-DI – Contact lenses: https://health.ec.europa.eu/document/download/c8c6cca5-460e-410e-a325-be08bfc7dea6_en?filename=mdcg_2024-14 _en.pdf
- Master UDI-DI Assignment
- Labelling Requirements
- Vigilance Reporting
- EUDAMED Registration
- Implementation Timeline
Artificial Intelligence in Medical Devices . Joint publication Team NB and IG-NB: https://www.team-nb.org/wp-content/uploads/2024/11/Team-NB-PositionPaper-AI-in-MDQuestionnaire-V1-20241125.pdf
Gradual Roll-out of EUDAMED – Be ready to start: https://health.ec.europa.eu/document/download/0e7327c7-0e06-4fbd-90d3-8ab7bb30fe9f_en?filename=md_mdcg_2024-11_eudamed-qa.pdf
Spain application for in-house devices – For hospitals: https://www.aemps.gob.es/informa/la-aemps-pone-en-marcha-una-nueva-aplicacion-para-la-comunicacion-de-fabricacion-de-productos-sanitarios-in-house-por-hospitales/

SMARTEYE

Eqms Smarteye: https://eqms-smarteye.com/

EVENTS

Arab Health – January 27 to 30th, 2025: https://medtechconf.com/event/total-radiology-conference/

TRAINING

Mini-Course MDR: https://easymedicaldevice.com/resource/resource-medical-device-regulation/mini-course-mdr/

ROW

US – Some healthcare software are not devices – WARNING: https://www.fda.gov/media/184083/download?attachment
- Administrative support in healthcare settings.
- Promoting healthy lifestyles without direct links to disease management.
- Serving as electronic patient records without interpreting or analyzing data.
- Transferring, storing, converting, or displaying medical data without interpretation.
- Providing limited clinical decision support to healthcare providers without interpreting clinical tests or device data.
US – PCCP Final guidance – Submit a PCCP with your submission: https://www.fda.gov/media/166704/download

• Webinar January 14, 2025 – https://www.fda.gov/medical-devices/cdrhnew-news-andupdates/webinar-final-guidance-marketing-submission-recommendations-predetermined-change-control-plan?utm_source=FDALinkedin

South Korea Guidance – Enhancing Medical Device Safety!: https://www.mfds.go.kr/law/board/boardDetail.do?menuKey=29&brdId=data0011&seq=15564

Australia – Guidelines for Medical Devices – Bookmark the link: https://www.tga.gov.au/resources/resource/reference-material/australian-regulatory-guidelines-medical-devices- argmd
Australia – Submit Custom-made device – Guidance step-by-step: https://www.tga.gov.au/resources/resource/user-guide/how-submit-custom-made-medical-device-notification
Malaysia – Advertisement application – Approve your Advertising: https://www.mda.gov.my/index.php/industry/medical-device-advertisements/medical-device-advertisement

PODCAST

How MDR and IVDR code can save you money? Stefan Bolleininger: https://podcast.easymedicaldevice.com/309-2/
Is FMEA bad for your Risk Management? Rod Beuzeval: https://podcast.easymedicaldevice.com/310-2/
How to build the perfect Quality Management System? https://podcast.easymedicaldevice.com/311-2/
IEC 60601-1-8 How to test your Medical Device Alarms? Beat Keller https://podcast.easymedicaldevice.com/312-2/
PCCP – The magic tool for planned changes in the US? Maria Diez: https://podcast.easymedicaldevice.com/313-2/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Medical Device News December 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

PCCP – The Magic tool for SaMD in the US?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 05 Dec 2024 00:00:00 +0000

In this episode, Maria Diez from CMGMedDev is explaining to us the PCCP tool for SaMD and why it can help a lot. We will also review US vs EU regarding changes to SaMD.

Who is Maria Diez?

María Diez is a seasoned expert in Quality Assurance (QA) and Regulatory Affairs (RA) for medical devices and in vitro diagnostic devices (IVDs), with over a decade of professional experience in the field. Holding a Ph.D. in Biochemistry and Molecular Biology, María has specialized in developing and maintaining Quality Management Systems (QMS) in compliance with standards such as ISO 13485, ISO 14971, and IEC 62304. She also brings extensive expertise in ensuring compliance with international medical device regulations, including those of the FDA, MDR, and IVDR. Additionally, María has significant experience in integrating advanced technologies, such as Artificial Intelligence (AI) and cybersecurity, into medical device software (MDSW) and Software as a Medical Device (SaMD).

Currently, María serves as a QA/RA Consultant at CMG MedDev, where she assists medical device manufacturers in bringing safe and effective products to market. Her expertise includes preparing technical documentation for CE marking, managing regulatory submissions for non-European markets, and helping companies navigate evolving global regulatory landscapes. María’s passion for education and innovation drives her active participation in industry conferences, where she shares her knowledge on AI-based MDSW/SaMD development and her experiences as a PRRC during the certification process.

Who is Monir El Azzouzi?

Link

Maria Diez LinkedIn: www.linkedin.com/in/maría-diez-zaera-46460323
CMGMedDev website: https://www.linkedin.com/company/cmgmeddev/posts/
PCCP guidance US:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/predetermined-change-control-plans-medical-devices

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post PCCP – The Magic tool for SaMD in the US? appeared first on Medical Device made Easy Podcast. hamza benafqir

IEC 60601-1-8 How to test your Medical Device alarms?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 28 Nov 2024 00:00:00 +0000

In this episode, Beat Keller from SMDC in Switzerland will help us to setup the right tests for your alarm systems. And you’ll see that it is not so obvious.

Who is Beat Keller?

Beat Keller is the founder and Managing Director of SMDC which supports medical devices to bring compliant medical devices on market quickly. Next to his experience in the medical device industry first as a software engineer, as project manager and later on as a regulatory affairs and quality manager, he is also member of different standardization working groups in Switzerland, on European level and internationally at IEC.

Who is Monir El Azzouzi?

Link

Beat Keller LinkedIn: https://www.linkedin.com/in/beat-keller/
SMDC website: https://www.smdc.ch
IEC 60601-1-8 Alarm System: https://webstore.iec.ch/en/publication/59648

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post IEC 60601-1-8 How to test your Medical Device alarms? appeared first on Medical Device made Easy Podcast. hamza benafqir

How to build the perfect Quality Management System?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 21 Nov 2024 00:00:00 +0000

In this episode, Monir El Azzouzi will help you build the perfect Quality Management System. He will give you his recipe to start the creation of a QMS and show you step by step what you should do.

Who is Monir El Azzouzi?

Link

Blog: Does your Quality Manual look like that? https://easymedicaldevice.com/quality-manual/
Video: How to get ISO 13485 certified? https://www.youtube.com/watch?v=paT2oR0uwjg
ISO 13485 standard: https://knowledge.bsigroup.com/products/medical-devices-quality-management-systems-requirements-for-regulatory-purposes?version=tracked
Blog: ISO 13485 Mandatory procedures: https://easymedicaldevice.com/iso-13485-procedure/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post How to build the perfect Quality Management System? appeared first on Medical Device made Easy Podcast. hamza benafqir

Is FMEA bad for your Risk Management?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 14 Nov 2024 00:00:00 +0000

In this episode, Rod Beuzeval will explain the reason why FMEA is maybe not the right method for your Risk Management per ISO 14971. So, check this and tell us if you agree.

Who is Rod Beuzeval?

Rod has 25+ years of experience in the medical device and pharmaceutical industry. He has expertise in regulatory strategy, technical documentation, QMS systems, standards compliance, clinical evaluation, risk management, project management, and remediation activities. Rod has worked for a notified body, conducted audits against EN ISO 13485, and supported reviews of technical documentation for medical device manufacturers in Europe. His experience includes Class I, II, and III devices, software as a medical device, drug delivery devices, IVDs, and active implantable medical devices.

Who is Monir El Azzouzi?

Link

Leap Compliance LinkedIn: www.linkedin.com/company/leap-compliance
Leap Compliance website: www.leapcompliance.com
ISO 14971 Standard: https://www.evs.ee/en/evs-en-iso-14971-2019
Video: What is ISO 14971: https://www.youtube.com/watch?v=5C2CzApjI_U
Podcast: Why Risk Management is important for Medical Devices: https://podcast.easymedicaldevice.com/207-2/
eQMS for Risk Management: https://eqms-smarteye.com/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Is FMEA bad for your Risk Management? appeared first on Medical Device made Easy Podcast. hamza benafqir

How MDR and IVDR code can save you money?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 07 Nov 2024 00:00:00 +0000

In this episode, Stefan Bolleininger will explain you can save money on your MDR or IVDR submission just by choosing the right MDR or IVDR code and by following some of his advice.

Who is Stefan Bolleininger?

Who is Monir El Azzouzi?

Link

Stefan Bolleininger Linkedin: https://www.linkedin.com/in/stefan-bolleininger-3a717028/
BeOnQuality Website: https://www.be-on-quality.com/
MDCG 2019-14 – MDR code: https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2019_14_mdr_codes_en_0.pdf
MDCG 2021-14 – IVDR code: https://health.ec.europa.eu/system/files/2021-07/md_mdcg_2021-14-guidance-ivdr-codes_en_0.pdf
EMDN Code: https://webgate.ec.europa.eu/dyna2/emdn/
Notified Body database NANDO : https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/by-legislation
eQMS for Medical Devices: https://eqms-smarteye.com/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post How MDR and IVDR code can save you money? appeared first on Medical Device made Easy Podcast. hamza benafqir

Medical Device News November 2024 Regulatory Update

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 31 Oct 2024 00:00:00 +0000

Medboard

https://www.medboard.com/

EU

Urgent update needed – EU MDR and IVDR: https://www.europarl.europa.eu/doceo/document/TA-10-2024-0028_EN.pdf

HMA communication: https://www.hma.eu/fileadmin/dateien/Medical_Devices/CGMD/241018_Letter.pdf

EU Commission Newsletter – What are the hot news: https://ec.europa.eu/newsroom/sante/newsletter-archives/56793

MDCG 2021-25 ;legacy devices & devices placed on the market prior to 26 May 2021: https://health.ec.europa.eu/document/download/cbb11a6e-f0f3-4e30-af5e-990f9ef68bc1_en?filename=md_mdcg_2021_25_en.pdf

Blog post article: https://easymedicaldevice.com/legacy-devices-clarification-with-mdcg-2021-25/

Notified Bodies Overview – How many still remaining: https://health.ec.europa.eu/do cument/download/3d407427-fad0-498a-b1ef-2db28c9f4423_en?filename=notifiedbodies_overview_en.pdf

New MDR NEOEMKI in Bulgaria: https://api.tech.ec.europa.eu/nando-prod/files?repo=nando&id=0e4e49a1afef458542254b3556a5e83d85321b23&group=NOTIFICATION&download=true

HPRA Notification for In-house Manufacturers – Frequently Asked Questions: https://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/sur-g0053-faq-on-notification-for-in-house-manufacturers-of-medical-devices-and-in-vitro-diagnostic-medical-devices-v1.pdf?sfvrsn=8

Harmonized Standards Summary List – For MDR and IVDR:

MDR: https://ec.europa.eu/docsroom/documents/62156/attachments/1/translations/en/renditions/native

IVDR: https://ec.europa.eu/docsroom/documents/62158/attachments/1/translations/en/renditions/native

MDCG 2024-11 – Qualification of IVDR: https://health.ec.europa.eu/document/download/12b92152-371f-404d-a865-93800cd5cdca_en?filename=mdcg_2024-11_en.pdf

PMS is not implemented correctly – IGJ report is shocking: https://english.igj.nl/binaries/igj-en/documenten/publication/2024/10/08/call-to-medical-device-manufacturers-implement-an-effective-pms-system/20241003_Call+to+medical+device+manufacturers+implement+effective+PMS+system.pdf

Blog post: https://easymedicaldevice.com/how-can-i-do-my-post-market-surveillance/

EUDAMED in Turkey – Message: You should use it: https://titck.gov.tr/duyuru/tcokka-tibbi-cihazlara-iliskin-avrupa-veri-tabani-hakkinda-teblig-taslagina-iliskin-duyuru-11102024094328

Turkey registration limited – 10 per individual: https://titck.gov.tr/duyuru/tibbi-cihaz-belge-ve-urun-kaydi-yapan-firma-ve-kullanicilarina-iliskin-duyuru-07102024151251

UK Post-Market Surveillance – New amendment: https://www.legislation.gov.uk/ukdsi/2024/9780348264593/data.pdf

Training

Team-NB training on Technical Documentation- November 6th: https://www.team-nb.org/wp-content/uploads/2024/07/Leaflet-MDR-TD-Manufacturers-Training-20241106.pdf

Events

MedtechConf events – Check the MAP

Afrisummit 2024 in Cairo November 3 to 6: https://medtechconf.com/event/afrisummit/
MEDxD 2024 In Berlin November 7th: https://medtechconf.com/event/medxd-medtech-meets-digital-2024/
Medica 2024 in Dusseldorf November 11th: https://medtechconf.com/event/medica-2024/

ROW

Australia

What is a Personalized Medical Device? – In Australia: https://www.tga.gov.au/sites/default/files/2024-10/understanding-personalised-medical-devices%20rules-including-3d-printed%20devices.pdf
How to submit a notification on custom-made device in Australia: https://www.tga.gov.au/sites/default/files/2023-12/How-submit-custom-made-medical-device-patient-matched-medical-device-notification-guide.pdf

Mexico

GMP for Mexico – Draft document: https://www.dof.gob.mx/nota_detalle.php?codigo=5734591&fecha=26/07/2024#gsc.tab=0

South Africa

South Africa and Australia MoU – Harmonization is on the way: https://www.sahpra.org.za/news-and-updates/south-african-and-australian-health-product-regulators-to-share-regulatory-information-and-expertise/

PODCAST

Podcast Nostalgia – Let’s review

Episode 306 – What are the TOP 3 issues on CAPA with Georg Digel: https://podcast.easymedicaldevice.com/306-2/
Episode 307 – What does a strategy for Regulatory Compliance Look like? https://podcast.easymedicaldevice.com/307-2/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Medical Device News November 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

What does a strategy for regulatory compliance looks like?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 24 Oct 2024 00:00:00 +0000

In this episode, Adam Isaacs Rae will help us shape your Regulatory Compliance Strategy. This is a requirement of the EU MDR and IVDR but it doesn’t provide much information. So, let’s review that together.

Who is Adam Isaacs Rar?

Who is Monir El Azzouzi?

Links from the Video

■ Adam Isaacs Rae linkedin Profile: https://www.linkedin.com/in/adam-isaacs-rae/
■ Webpage The Other Consultants: theotherconsultants.com

Social Media to follow

■ Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
■ Twitter: https://twitter.com/elazzouzim
■ Pinterest: https://www.pinterest.com/easymedicaldevice
■ Instagram: https://www.instagram.com/easymedicaldevice

The post What does a strategy for regulatory compliance looks like? appeared first on Medical Device made Easy Podcast. hamza benafqir

What are the TOP 3 issues on CAPAs?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 17 Oct 2024 00:00:00 +0000

in this episode, Georg Digel will help use solve 3 major problems with our CAPAs. He will tell you what these problems within your Quality Management System are and propose some solution. We will also talk about the education of the team.

Who is Georg Digel?

I’ve reviewed too many Medical Device CAPAs over the last 10 years. I think I’ve seen almost every mistake there is …Some of my “favorites”:

– Initiating CAPA without gathering facts
– Setting up KPIs but not monitoring them
– Confusing Correction with Corrective Action

To be honest – I’ve made many of these mistakes myself.

Luckily, I learned and improved. Over time, I even took on bigger responsibilities. Some projects which I really enjoyed:

– Process harmonizations for 60 sites
– Setup of training programs for 1.000+ people
– KPI dashboard implementations for 813 CAPAs

My learnings were paired with painful experiences. I want to save you from all of them. My goal is to help you:

1. Avoid CAPA related audit findings or 483s
2. Implement meaningful metrics for your CAPAs
3. Train your people so they close records effectively

Who is Monir El Azzouzi?

Link

Georg Digel LinkedIn: https://www.linkedin.com/in/georgdigel/
Vincent Cafiso Podcast episode: Are you More Corrections or Corrective Actions or Preventive actions? https://www.youtube.com/watch?v=YsXfBv_AdWc
How to be the best at CAPAs with Karandeep Badwal: https://www.youtube.com/watch?v=zWK1U7d2awY
Most important issues on CAPAs: https://www.youtube.com/watch?v=lR4r14V5oHA

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post What are the TOP 3 issues on CAPAs? appeared first on Medical Device made Easy Podcast. hamza benafqir

Medical Device News, October 2024 Regulatory Update

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 10 Oct 2024 00:00:00 +0000

Medboard: https://www.medboard.com/

EUROPE

TEAM NB – Code of Conduct for NB – Version 5: https://www.team-nb.org/wp-content/uploads/2024/09/PressRelease-CoC-20240916.pdf
TEAM NB – IVDR Transition – Transition to the implementation of Class D oversight by EURLs: https://www.team-nb.org/wp-content/uploads/2024/10/PressRelease-ClassD-20241001.pdf
MDCG 2021-4 Rev 1 update- Deletion, revision, addition of questions: https://health.ec.europa.eu/document/download/9f23fca0-f407-4e45-a464-2d71b575d1fe_en?filename=mdcg_2021-4_en.pdf
Swissmedic – Deadline for Swissdamed – November 13th, 2024: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/overview-medical-devices/archive/swissdamed/swissdamed-frist-13-11-24.html
Swiss review of old legislation devices – Check that all are up-to-date: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/overview-medical-devices/aufforderung-ueberpruefung-altrechtlicher-produkte.html
UK on their new Regulation – Restart ongoing: https://medregs.blog.gov.uk/2024/09/25/an-update-on-our-plans-for-med-tech-regulatory-change/

EVENTS

TEAM-PRRC – October 17-18. 2024: https://medtechconf.com/event/team-prrc-third-annual-summit/
Afrisummit – November 3-6, 2024: https://medtechconf.com/event/afrisummit/
MEDICA – November 11-14, 2024 : https://medtechconf.com/event/medica-2024/

NB

ISS IVDR Notified Body – ISTITUTO SUPERIORE DI SANITA’: https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/notifications/1010586?organizationVersion=3

ROW

Middle East

Saudi Arabia: Labelling Guidance – What should contain a Medical Device Label in Saudi Arabia: https://www.sfda.gov.sa/sites/default/files/2024-10/MDS-014En.pdf

Northern America

USA webinar on Registation & Listing Requirements – In-Vitro Diagnostics and Laboratory Developed Tests: https://www.fda.gov/medical-devices/cdrhnew-news-and-updates/webinar-registration-listing-requirements-in-vitro-diagnostic-products-ivds-including-laboratory
USA Guidance on Dental products – Air Powered handpiece, Dental Cements, Dental Ceramics, Impressions:
Canada policy on Drug/device combinations – Who is who?: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/policies/policy-drug-medical-device-combination-products-decisions.html

South America:

Brazil bans – Thermometers and Sphygmomanometers with a Mercury column: https://antigo.anvisa.gov.br/documents/10181/6873945/RDC_922_2024_.pdf/1e09cbf1-53db-4609-bea7-34afb7ce633c

PODCAST

Podcast Nostalgia – Last podcast to listen to-
- Episode 302 – How to do PMCF literature Search for Medical Devices with Cesare Magri 4BetterDevices: https://podcast.easymedicaldevice.com/302-2/
- Episode 303 – UK vs EU vs US – How to switch to another region easily? With Claire Dyson DQS : https://podcast.easymedicaldevice.com/303-2/
- Episode 304 – How to select the best plastic for your Medical Device? Lucas Pianegonda Gradical: https://podcast.easymedicaldevice.com/305-2/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Medical Device News, October 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

How to select the best plastic for your Medical Device?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 03 Oct 2024 00:00:00 +0000

In this episode, Lucas Pianegonda will help us to select the right material for your medical device and also answer questions that you maybe would love to hear his answer. We will also talk about sustainability for plastics. So check this.

Who is Lucas Pianegonda?

Lucas Pianegonda is an expert for medical grade plastics, material testing and material compliance. He has experience as a material expert in ISO 13485 certified companies of several years, he knows the requirements the MDR makes towards medical devices and can translate these into material requirements. He has lead multiple projects on an international level successfully for topics like material change-overs, IP, bio compatibility and second source material qualification.

He is a self driven, communicative and assertive person, he loves challenges and he strives always for self improvement.

Who is Monir El Azzouzi?

Link

Lucas Pianegonda LinkedIn: https://www.linkedin.com/in/lucas-r-pianegonda-81142b110/?locale=en_US
Gradical website: https://gradical.ch/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post How to select the best plastic for your Medical Device? appeared first on Medical Device made Easy Podcast. hamza benafqir

UK vs EU vs US – How to switch to another region easily?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 24 Sep 2024 00:00:00 +0000

In this episode, Claire Dyson will give us the recipe to launch correctly your Medical Device when you go abroad and for that we will take the example of EU and US.

Who is Claire Dyson?

Who is Monir El Azzouzi?

Links from the Video

Claire Dyson Linkedin page: https://www.linkedin.com/in/claire-dyson-85845b4b/
DQS website: https://www.dqsglobal.com/gb-en/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/

The post UK vs EU vs US – How to switch to another region easily? appeared first on Medical Device made Easy Podcast. hamza benafqir

How to do a PMCF Literature Search for Medical Devices?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 17 Sep 2024 00:51:39 +0000

In this episode, Cesare Magri will try to improve our skills on PMCF literature search. We will investigate on the misconceptions and what people should make to do it right.

Who is Cesare Magri?

Cesare Magri is the founder and CEO of 4BetterDevices GmbH. He and his team of medical doctors and biostatisticians assist medical device and in-vitro diagnostic manufacturers by leveraging clinical and non-clinical data for certification and marketing purposes. He has contributed to more than 100 clinical and performance evaluation for devices of all risk classes.

Who is Monir El Azzouzi?

Links from the Video

Cesare Magri LinkedIn: https://www.linkedin.com/in/cesare-magri/
4BetterDevices website: https://4betterdevices.com/
Evidence link: https://evidence.systems

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post How to do a PMCF Literature Search for Medical Devices? appeared first on Medical Device made Easy Podcast. hamza benafqir

Medical Device News, Septembre 2024 Regulatory Update

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 10 Sep 2024 00:58:42 +0000

EU

e-IFU for medical devices – Consultation ongoing: https://ec.europa.eu/eusurvey/runner/Survey_eIFUs_medicaldevices_2024?surveylanguage=EN
MDR Transition period – Visual timeline: https://health.ec.europa.eu/document/download/06bb3982-dc01-46aa-95af-d8833c9fcb21_en?filename=timeline_mdr_en.pdf
Implementing Act IVDR Common specifiaction – Consultation until Sept 16th: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14383-In-vitro-diagnostic-medical-devices-common-specifications_en
Cyber Security in Health and medicine – Results from Cyber incidents: https://op.europa.eu/o/opportal-service/download-handler?identifier=9d3355cf-591f-11ef-acbc-01aa75ed71a1&format=pdf&language=en&productionSystem=cellar&part=
How much cost a Notified Body? – Links available: https://health.ec.europa.eu/document/download/ff5716d5-fe77-4f45-b883-fcf3da4acd15_en?filename=md_nbs_fees_en.pdf

Switzerland

Swiss Combined Studies – Information Sheet to read: https://www.swissmedic.ch/dam/swissmedic/it/dokumente/medizinprodukte/mep_urr/bw600_00_017e_mb_combined_studies.pdf.download.pdf/BW600_00_017e_MB_Information_combined_studies_KlinV_KlinVMEP.pdf
3D Printing for Medical Devices – Reminder from Swissmedic: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/mu600_00_017d_mb_3d-drucker_mep.pdf.download.pdf/MU600_00_017e_MB_3D_printers_medical_devices.pdf

Training

EU MDR training September 23rd – Register Now: https://school.easymedicaldevice.com/course/gb33/

Events:

RAPS Convergence – September 17th to 19th California: https://medtechconf.com/event/raps-convergence-2024/
AI ACT SUMMIT – October 1st :Online : https://medtechconf.com/event/ai-act-summit/
Team-PRRC – October 17th – Malaga: https://medtechconf.com/event/team-prrc-third-annual-summit/
Afrisummit – November 3-6 – Egypt: https://www.pharmaregafrisummit.com/
Meds’d – November 7th – Berlin: https://medtechconf.com/event/medxd-medtech-meets-digital-2024/

ROW

Australia:
- Webinar: Software transition deadline on 1 November 2024 Reclassification needed: https://www.tga.gov.au/resources/event/webinars/software-reclassification-reforms-webinar-q-and-software-transition-deadline-1-november-2024
USA
- Voluntary malfunction Summary Reporting (VSMR) – Support the system: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/voluntary-malfunction-summary-reporting-vmsr-program-manufacturers
- FDA Webinar: Remanufacturing of Devices – Distinction between servicing and remanufacturing: https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/webinar-final-guidance-remanufacturing-medical-devices-09102024?utm_source=FDALinkedin
- FDA DeNovo – Electronic Submission template: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/electronic-submission-template-medical-device-de-novo-requests
- PCCP Draft Guidance – Plan your changes so they don’t need a review again: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/predetermined-change-control-plans-medical-devices
Brazil:
- Brazil UDI project – The world will be UDI soon: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2024/saiba-mais-sobre-o-projeto-de-identificacao-unica-de-dispositivos-medicos
- Brazil Vigilance Reporting – e-Notivisa Launch: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2024/cidadaos-poderao-notificar-eventos-adversos-de-dispositivos-medicos-pelo-e-notivisa
Singapore
- Singapore Change Management Program – Consultation on SaMD Guidance: https://www.hsa.gov.sg/announcements/regulatory-updates/consultation-on-guidance-on-change-management-program-(cmp)-for-samd
Bahrain
- Guidance for registration of Medical Devices – Screenshot included: https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/guidelines/Medical%20Device%20Importation%20Guideline-%20Ver%2011.1.pdf

Medical Device Live Expert:

Medical Device Live Expert – July August:
- MDLE #2 – US EXPERT: Medical Device Live Expert #2 – US is in the place
- MDLE #3 – EU MDR and IVDR Future: MDLE #3 – The Future of the MDR in EU, What Is?

Podcast

Podcast Nostalgia – July and August
- AI ACT – What are the challenges for Medical Devices? Fabien Roy https://podcast.easymedicaldevice.com/292-2/
- EU Battery Regulation – How to be ready? Erik Vollebregt: https://podcast.easymedicaldevice.com/293-2/
- How to register your Medical Device in the UAE? Ahmed Hendawy: https://podcast.easymedicaldevice.com/294-2/
- EU MDR majow update: Interruption or Discontinuation of Supply! Erik Vollebregt: https://podcast.easymedicaldevice.com/295-2/
- IVDR Class D – Lesson learned from Notified Bodies. Andreas Stange: https://podcast.easymedicaldevice.com/296-2/
- How to use Harmonised Standards for Devices? Beat Keller: https://podcast.easymedicaldevice.com/297-2/
- Manage the Transfer/Renewal/ Surveillance/Change of your CE Certificate. Ralf Gansel: https://podcast.easymedicaldevice.com/298-2/
- How to grow from Zero to Hero in Medical Device? Stephan O’Rourke: https://podcast.easymedicaldevice.com/299-2/
- Episode 300: How to use AI GPT for your QA RA work? Martin King: https://podcast.easymedicaldevice.com/300-2/

The post Medical Device News, Septembre 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

How to use AI GPT for your Quality and Regulatory work?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 05 Sep 2024 10:09:09 +0000

In this episode, Martin King will share with us his practice of AI in the context of Quality and Regulatory affairs for medical devices. This will explain to you some best practices to maintain to avoid some pitfalls.

Who is Martin King?

Martin Cranston King, a Swiss consultant working with medical devices, in vitro diagnostics (IVD), and pharmaceuticals since 1979. Martin is a leading expert in quality assurance, regulatory compliance, and product development, developing active wearable devices since the 1980s.

Known for his hands-on approach and deep understanding of complex regulatory environments, Martin has guided companies around the globe through successful regulatory submissions. His expertise spans across six continents, making him a sought-after advisor in his field.

Martin holds advanced degrees in Micro-electronics and Materials Science, and Electronic Engineering. He is a trained Lead Auditor for ISO 13485:2016 and is well-versed in international standards such as 21 CFR 820 and MDR 745/2017. Recognized as one of the top 25 MedTech Leading Voices on LinkedIn, Martin also shares valuable insights through his popular weekly regulatory roundup.

Who is Monir El Azzouzi?

Link

Martin Kings LinkedIn: https://www.linkedin.com/in/martink2/
QARA Whatsapp group: https://chat.whatsapp.com/Dkl3XrjiXzW51Fgipf96k2
QARA Whatsapp channel: https://whatsapp.com/channel/0029VaaBTj9CxoAwG0CUBn1x

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post How to use AI GPT for your Quality and Regulatory work? appeared first on Medical Device made Easy Podcast. hamza benafqir

How to go from Zero to Hero in Medical Devices?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 27 Aug 2024 00:00:00 +0000

In this episode, Stephen O’Rourke that was not working within the Medical Device industry will share with us is journey from Zero knowledge in the field to running projects. Listen to his journey in case you are also willing to breakthrough the medical device field.

Who is Stephen O’Rourke?

Stephen O’Rourke, based in Berlin, Germany, is a seasoned regulatory affairs expert with extensive experience across the food, biotech, and medical device industries. With deep expertise in EU and global regulations, he is dedicated to helping companies navigate complex regulatory landscapes, ensuring the successful launch of innovative products. His journey and transition into medical device regulation began at one of Europe’s largest clinics, where he was instrumental in kickstarting their MDR consultancy. Outside of his regulatory work, Stephen is an advocate for transparency and accountability in politics, having run for the European Parliament in 2024 to champion these causes. He is also actively involved in promoting Ireland’s traditional sports and enjoys exploring Berlin with his family.

Who is Monir El Azzouzi?

Link

Stephen O’Rourke LinkedIn: https://www.linkedin.com/in/sorourkede/
AI Act Summit Link: https://medtechconf.com/event/ai-act-summit/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post How to go from Zero to Hero in Medical Devices? appeared first on Medical Device made Easy Podcast. hamza benafqir

Manage the Transfer/Renewal/Surveillance/Change of your CE certificate

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 20 Aug 2024 00:00:00 +0000

In this episode, I have invited Ralf Gansel to help us understand the process for Certification of your product and what is the lifecycle for it. We’ll discuss about Transfer or certificates, or notification of changes or why there is a renewal and not continuous surveillance…

Who is Ralf Gansel?

With over a decade of experience in the medical health sector and equipped with a subtly dry sense of humor, Ralf committed to bringing transformative medical technologies to the EU and global markets by leveraging his extensive expertise in regulatory frameworks and market dynamics.

At TÜV SÜD in the Medical & Health Services Business Unit , Ralf head the Special Operations and Support department. He is specialized in onboarding and supporting new clients, dealing in the field of active and non-active devices, implantables, and IVDs. His role focuses on advancing technological innovations and ensuring their market success while meeting EU and international regulatory requirements.

Who is Monir El Azzouzi?

Link

Ralf Gansel LinkedIn: https://www.linkedin.com/in/ralf-gansel/
TÜV SÜD website: https://www.tuvsud.com/en/industries/healthcare-and-medical-devices/medical-devices-and-ivd/medical-device-market-approval-and-certification/medical-device-regulation/mdr-request-for-service-registration

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Manage the Transfer/Renewal/Surveillance/Change of your CE certificate appeared first on Medical Device made Easy Podcast. hamza benafqir

How to use Harmonized Standards for Medical Devices?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Wed, 14 Aug 2024 00:51:00 +0000

Medical Devices should follow some standards but if these standards are harmonized this brings them to another level. This will be a great discussion with Beat Keller on how to use them correctly.

Who is Beat Keller?

Who is Monir El Azzouzi?

Link

Beat Keller LinkedIn: https://www.linkedin.com/in/beat-keller/
SMDC website: https://www.smdc.ch
EU IVDR harmonized standards: https://single-market-economy.ec.europa.eu/single-market/european-standards/harmonised-standards/iv-diagnostic-medical-devices_en
Swiss harmonized standards: https://www.switec.info/de/neue-harmonisierte-normen/
US FDA Recognized Consensus Standards: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/results.cfm

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post How to use Harmonized Standards for Medical Devices? appeared first on Medical Device made Easy Podcast. hamza benafqir

IVDR Class D – Lesson learned from Notified Bodies

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 06 Aug 2024 09:52:16 +0000

The EU IVDR is in place and we will focus on this episode on Class D devices. Andreas Stange will explain to us what TÜV SÜD learned from the 100^th class D certificates they issued. We will also review the timeline for IVDR and explain the next deadline which is in October. So be aware of it now.

Who is Andreas Stange?

Dr. Andreas F. Stange is a vice president for the Medical and Health Services group at TÜV SÜD. Product Service. He serves as the global responsibility for the In-vitro Diagnostic Devices business line. Besides that, he is also overseeing TÜV SÜD`s Medical Health Services in North-East Asia. Dr. Stange joined TÜV SÜD in 2001 as a medical device expert and had various positions since then in the group. Before taking the current position in March 2017, he served as President & CEO of TÜV SÜD in Japan for eight years.

Who is Monir El Azzouzi?

Link

Andreas Stange Linkedin Profile: https://www.linkedin.com/in/andreasstange/
TÜV SÜD Website: https://www.axonlawyers.com/
EU IVDR: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0746-20230320

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post IVDR Class D – Lesson learned from Notified Bodies appeared first on Medical Device made Easy Podcast. hamza benafqir

EU MDR Major update: Interruption or Discontinuation of supply!

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 30 Jul 2024 03:11:00 +0000

The EU MDR is still not stable. There are still updates ongoing so stay tuned and listen to Erik Vollebregt explaining the Article 10a that will be integrated to the EU MDR where medical device manufacturers have to inform about interruption of supply. So what will be the requirements and what should you do. Listen to it to know more.

Who is Erik Vollebregt?

Erik specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software, and protection of personal data. He is an expert in life sciences regulation at the EU and Dutch level, with a focus on contracts, and regulatory litigation against competent authorities and M&A. Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms. He actively contributes to law and policy development at the national and EU levels via membership in specialized committees at branch associations and the European Commission. Erik also works as an arbitrator in medical devices-related disputes and is regularly retained as an expert witness in foreign litigation. Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish. Chambers Europe 2017: Erik is known for his specialism in regulatory work, which covers medical technology, devices, and products as well as for biotechnology. Clients confirm his strong capabilities, with one saying “he stands out to me. Whenever I work with lawyers he has been the best, with a solid scientific background. He has the perfect combination of skills and experience.” 

Who is Monir El Azzouzi?

Link

Erik Vollebregt Linkedin Profile: https://www.linkedin.com/in/erikvollebregt/
Axon Lawyers Website: https://www.axonlawyers.com/
EU MDR: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0745-20230320
Medical devices: Council adopts new measures to help prevent shortages https://data.consilium.europa.eu/doc/document/PE-54-2024-INIT/en/pdf
Article Judith de Wildth – How to prepare for article 10a: https://www.linkedin.com/posts/erikvollebregt_how-to-prepare-for-article-10a-mdr-as-a-manufacturer-activity-7216378083308646401-vqzF
EUDAMED roll-out timeline: https://health.ec.europa.eu/document/download/04ce2012-97df-4dd0-8a39-d4f6993b9e16_en?filename=md_eudamed_roadmap_en.pdf

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post EU MDR Major update: Interruption or Discontinuation of supply! appeared first on Medical Device made Easy Podcast. hamza benafqir

How to register your Medical Device in the UAE?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 23 Jul 2024 00:00:00 +0000

Registration of Medical Devices can be complicated. But here we will share with you the process for the United Arab Emirate where the famous city of Dubai is located. Ahmed Hendawy from Registitute is helping us to understand this process and he confirms that it is really simple. So no way that you miss this.

Who is Ahmed Hendawy?

Ahmed is an esteemed leader in the field of healthcare consulting, renowned for his deep expertise in healthcare regulations, market access, and business strategy within the MENA region. As the founder and driving force behind Registitute, Ahmed has established the firm as a premier provider of specialized services in regulatory affairs and market access. With a distinguished career, including a previous role as the Head of Regulatory Affairs for the MENA region, Ahmed has demonstrated exceptional skill in navigating complex regulations and spearheading successful market entry strategies. Under his visionary guidance, Registitute has garnered a reputation for excellence and innovation in the healthcare consulting landscape. Registitute stands apart by delivering tailored solutions that address the unique challenges faced by healthcare organizations operating in the MENA region. Ahmed’s strategic vision, combined with the expertise of the Registitute team, continues to drive positive change and support healthcare organizations in adapting to the ever-evolving healthcare landscape in the MENA region. In summary, Ahmed’s leadership and Registitute’s unwavering commitment to providing exceptional services position them as a trusted partner for healthcare organizations seeking regulatory expertise and market access support in the MENA region.

Who is Monir El Azzouzi?

Links from the Video

Ahmed Hendawy Linkedin : https://www.linkedin.com/in/ahmed-hendawy-a0a81511a
Registitute LinkedIn: https://www.linkedin.com/company/registitute/
Registitute Website : www.registitute.com
AL TIRYAQ LinkedIn : https://www.linkedin.com/company/al-tiryaq/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post How to register your Medical Device in the UAE? appeared first on Medical Device made Easy Podcast. hamza benafqir

EU Battery Regulation – How to be ready?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 16 Jul 2024 00:00:00 +0000

More and more regulations have to be applied parallel to the EU MDR and the one of the EU Battery Regulation is not an exception. Erik Vollebregt from Axon Lawyers will explain these additional requirements to us. He will also confirm that Notified Bodies can ask you questions about it and finally, he will share some key timelines for its implementation. Spoiler Alert! first is August 2024 so be quick.

Who is Erik Vollebregt?

Who is Monir El Azzouzi?

Links from the Video

Erik Vollebregt Linkedin Profile: https://www.linkedin.com/in/erikvollebregt/
Axon Lawyers Website: https://www.axonlawyers.com/
EU Battery Regulation: https://data.consilium.europa.eu/doc/document/ST-10488-2023-INIT/en/pdf
Blog Post EU Battery Regulation: https://easymedicaldevice.com/eu-battery-regulation-2023-1542-impact-medical-devices/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post EU Battery Regulation – How to be ready? appeared first on Medical Device made Easy Podcast. hamza benafqir

AI Act – What are the challenges for Medical Devices?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 09 Jul 2024 00:08:00 +0000

You are working with a Software that contains an AI/ML algorithm then you should listen to this podcast episode and understand the requirements of the AI ACT to your medical device. Fabien Roy, lawyer will explain to us what are the challenges that he has identified for medical device manufacturers working with Artificial Intelligence.

Who is Fabien Roy?

I am an EU pharma/device lawyer and problem solver. My practice focuses on European Union (EU) and national regulatory matters involving medical devices and pharmaceutical laws and guidelines. I am following very closely the new regulations on medical devices (MDR and IVDR), the GDPR and regularly advise clients in relation to the requirements applicable to their digital health technologies. I focus particularly on the different stages of the medical device CE marking process and advise on a wide variety of topics which include the following:

– determination of the appropriate classification of individual products;
– clinical investigation procedure (e.g. authorisation from the EU Member States competent authorities, opinion from Ethics Committee, amendment to the Protocol, informed consent, serious adverse event qualification and notification, handling of personal data);
– drafting of clinical investigation and clinical trial agreements, distribution agreements and contract manufacturing agreements;
-clinical data requirements and clinical evaluation;
– conformity assessment procedure;
– review of Instruction For Use, products’ labelling and promotional material including websites;
– post-marketing surveillance activities including the notification of adverse event, product recall or product withdrawal;
– preparation and review of technical documentation;
– reimbursement. I also advise on questions regarding marketing authorisation procedures, variation procedures, and clinical trials, promotional and marketing activities in the pharmaceutical sector. Specialties: Regulation of medical devices and medicinal products in the EU

Who is Monir El Azzouzi?

Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device field pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.

Link:

Fabien Roy Linkedin Profile: https://www.linkedin.com/in/fabien-roy-83b55021/
Company Website: https://www.hoganlovells.com/
Ai Act text: https://www.europarl.europa.eu/doceo/document/TA-9-2024-0138_EN.pdf

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post AI Act – What are the challenges for Medical Devices? appeared first on Medical Device made Easy Podcast. hamza benafqir

Medical Device News, July 2024 Regulatory Update

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Fri, 05 Jul 2024 07:17:33 +0000

Medboard

EU

Germany warns against overregulation of Medical Devices – Is it not too late: https://www.bundestag.de/presse/hib/kurzmeldungen-1006422
- Title: MDR and IVDR next steps – Subtitle: Erik Vollebregt points: https://medicaldeviceslegal.com/2024/06/04/the-german-angle/
MDCG 2022-13 Rev1 – Extension of the scope of designations: https://health.ec.europa.eu/document/download/27f91dc2-b5bc-44f9-a975-5024ce3ea556_en?filename=mdcg_2022-13_en.pdf
MDCG 2024-10 Clinical Evaluation of orphan medical devices : For RARE DISEASES: https://health.ec.europa.eu/document/download/daa1fc59-9d2c-4e82-878e-d6fdf12ecd1a_en?filename=mdcg_2024-10_en.pdf
Scheer – Brain Stimuilators -: Risks associated with Brain Stimulators: https://health.ec.europa.eu/consultations/scheer-call-external-experts-scheer-wg-risks-health-associated-use-brain-stimulators-not-having_en
Fast access to Clinical Trial Information -: New CTIS: https://www.ema.europa.eu/en/news/faster-access-clinical-trial-information-europe
AI Supervision required – AI ACT: https://www.autoriteitpersoonsgegevens.nl/en/current/ap-and-rdi-supervision-of-ai-systems-requires-collaboration-and-must-be-arranged-quickly

UK

UK USA and Canada on AI – Guiding Principles: https://assets.publishing.service.gov.uk/media/66670b9be8d5f2d4bdfcbb37/transparency_ml-enabled_devices_guiding_principles.pdf

Swiss

SWISSDAMED Actors Module – Open in August 6th, 2024: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank/release-notes.html

MEDTECH CONF

Medicall August 2nd 2024 – Chennai, India: https://medtechconf.com/event/medicall-chennai-2024/
RAPS Convergence Sept 17-19 2024 – Long Beach, California, USA: https://medtechconf.com/event/raps-convergence-2024/
AI Act Summit October 1st 2024 – Strasbourg, France: https://medtechconf.com/event/ai-act-summit/

LIVE SESSION

Medical Device Live Expert #1 – Replay: https://www.youtube.com/watch?v=RrzXj36Yrqc

Medical Device Live Expert #2 – US is in the place: https://www.linkedin.com/events/medicaldeviceliveexpert-2-usais7214180765008359424/theater/

US

Essential Drug Delivery Outputs for Devices Guidance – Learn FDA requirements for EDDOs: https://www.fda.gov/media/179545/download
Recognized Standards – Change happens: https://www.govinfo.gov/content/pkg/FR-2024-06-24/pdf/2024-13777.pdf
US Webinar IVD classification -: July 16th 1pm EST: https://www.fda.gov/medical-devices/medical-devices-news-and-events/webinar-in-vitro-diagnostic-product-ivd-classification-07162024
Blog post – The promise of AI in Health Care – FDA knows: https://www.fda.gov/medical-devices/digital-health-center-excellence/blog-promise-artificial-intelligence-holds-improving-health-care

Australia

Australia: Exempt Medical Device – They should still follow the rules: https://www.tga.gov.au/resources/resource/guidance/regulatory-obligation-exempt-medical-devices
Cosmetics or therapeutics -TGA helps you to decide: https://www.tga.gov.au/sites/default/files/2024-06/cosmetics-therapeutic-goods-guidance-for-advertisers-suppliers.pdf
: Essential Principle Checklist -Template available: https://www.tga.gov.au/resources/resource/checklists/essential-principles-checklist
AusUDID is in the place – Australian UDI Database for sponsors and manufacturers: https://www.tga.gov.au/how-we-regulate/manufacturing/manufacture-medical-device/unique-device-identification-udi-hub/udi-information-sponsors-and-manufacturers/australian-udi-database-sponsors-and-manufacturers

Saudi Arabia

Extend Shelf Life – in case of Public emergency: https://tinyurl.com/EMDpod

Malaysia

Workshop Post-Market Requirements – July 16th, 2024: https://www.autoriteitpersoonsgegevens.nl/en/current/ap-and-rdi-supervision-of-ai-systems-requires-collaboration-and-must-be-arranged-quickly
Training: How to submit documents – July 17th, 2024: https://portal.mda.gov.my/index.php/doclink/program-8-hands-on-medcrest-post-market-pdf/eyJ0eXAiOiJKV1QiLCJhbGciOiJIUzI1NiJ9.eyJzdWIiOiJwcm9ncmFtLTgtaGFuZHMtb24tbWVkY3Jlc3QtcG9zdC1tYXJrZXQtcGRmIiwiaWF0IjoxNzE4MjQ5OTgzLCJleHAiOjE3MTgzMzYzODN9._ZObFPlzSpQWnAoPKDxH_J8IWhmcTDNLsFpYe0AkO9M
Are you satisfied with Malaysia MDA – You can rate here: https://www.mda.gov.my/index.php/news/1418-kajian-kepuasan-pelanggan-mda-1-2024

South Africa

SAHPRA Medical Device Vigilance- Who to contact: https://www.sahpra.org.za/wp-content/uploads/2024/06/Contacts-for-Adverse-Events-Recalls-and-Market-Actions.pdf

PODCAST

Episode 288 – Cleaning Validation – How to select the worst case (Heena Thakkar): https://podcast.easymedicaldevice.com/288-2/
Episode 289 – AFNOR- How is a Notified Body designated: (Thomas Lommatzsch): https://podcast.easymedicaldevice.com/289-2/
Episode 290 – How to submit your AI/ML SAMD the right way? (Richie Christian): https://podcast.easymedicaldevice.com/290-2/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Medical Device News, July 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

How to submit your AI/ML SAMD the right way?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 25 Jun 2024 00:00:00 +0000

You don’t know what a regulator will say when seeing your AI/ML Software, then listen to this episode. Richie Christian will explain the important elements that you should take care off before to submit your dossier to your Notified Body or your Competent Authority. So enjoy.

Who is Richie Christian?

Richie Christian has more than 10 years of experience in medical device regulatory and quality. He has a Master’s degree in neurophysiology from the University of Auckland, and is passionate about digital transformation of the healthcare industry. Throughout his career, Richie has worked in numerous regulatory and quality roles with not only traditional hardware device manufacturers, but also cutting-edge AI/ML-enabled SaMD manufacturer.

In his most recent role as the Head of Regulatory and Quality, he spearheaded the development and implementation of a streamlined QMS, enabling them to achieve MDSAP certification and secure market authorisations for an innovative orthopaedics AI/ML-enabled SaMD in USA and Japan.

Richie relocated to Basel, Switzerland from New Zealand as a consultant for wega Informatik where he now applies his decade-long experience to help companies develop and deliver compliant medical device software.

Who is Monir El Azzouzi?

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post How to submit your AI/ML SAMD the right way? appeared first on Medical Device made Easy Podcast. hamza benafqir

AFNOR – How is a Notified Body designated?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 18 Jun 2024 00:00:00 +0000

If you are looking for selling your medical devices in Europe, you will then maybe need a Notified Body unless your product is class I. In this episode, we talk with Thomas Lommatzsch about the process of designation and why it is so difficult. We will also cover some questions regarding the auditors, the costs, the audit by the competent authorities… So stay tuned.

Who is Thomas Lommatzsch?

Thomas LOMMATZSCH heads the Medical Business Unit of AFNOR Certification, which deals with the certification of medical devices within the notified body AFNOR Certification (NB0333). With over 20 years’ experience within Notified Bodies under various European regulations, he has completed several notification projects, most recently the AFNOR Certification notification project under the MDR. Thomas is also involved in standardization work relating to the application of the AI Act, particularly with its application to medical devices.

Who is Monir El Azzouzi?

Link

Thomas Lommatzsch Linkedin Profile: https://www.linkedin.com/in/thomas-lommatzsch/
AFNOR webpage: https://certification.afnor.org/qualite/marquage-ce-dispositifs-medicaux
EU MDR 2017/745: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0745-20230320
EU IVDR 2017/746: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0746-20230320
French competent authority ANSM: https://ansm.sante.fr/
JAT Joint Assessment: https://health.ec.europa.eu/document/download/b9d671f5-02d0-44b1-a207-b07aeb4ef931_en?filename=md_info_ja_mdr_en.pdf
MDCG 2022-13 Designation, re-assessment and notification of conformity assessment

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post AFNOR – How is a Notified Body designated? appeared first on Medical Device made Easy Podcast. hamza benafqir

Cleaning Validation – How to select the worst case?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 11 Jun 2024 00:00:00 +0000

Have you ever had to deal with Cleaning Validation. If yes than you know the pain to select the instruments and group them and for each group find a worst case. On this episode, we tell you how this should be working so you can guarantee to provide clean products and clean instructions to your customers.

Who is Heena Thakkar?

Heena Thakkar is a regulatory consultant currently working with Alceon Medtech Consulting. She is based in Gujarat, India. Heena is qualified in risk management, design controls, usability engineering, clinical evaluation, clinical trial management, quality management systems and process validation. She is also a certified internal auditor.

Heena has around 8 years of experience in the field of regulatory affairs and quality management system for medical devices. She is experienced in regulatory submissions for vast range of devices ranging from orthopaedic devices, endovascular devices, single-use consumables, ophthalmic devices and wound care devices. She also conducts external trainings in the areas such as risk management, quality management system, EU MDR and EU IVDR.

Who is Monir El Azzouzi?

Link

Heena Thakkar Linkedin Profile:

https://www.linkedin.com/in/heenathakkar?utm_source=share&utm_campaign=share_via&utm_content=profile&utm_medium=ios_app

Alceon Medtech Consulting Website:

Home

List of standards helpful for cleaning validation of reusable instruments

ANSI/ AAMI ST98: Cleaning validation of health care products—Requirements for development and validation of a cleaning process for medical devices https://www.aami.org/standards/featured-standards/aami-st98

USFDA Guidance: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (https://www.fda.gov/media/80265/download)

ISO 17664-1:2021: Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices – Part 1: Critical and semi-critical medical devices (https://www.iso.org/standard/81720.html)

ISO 15883-1:2006: Washer-disinfectors – Part 1: General requirements, terms and definitions and tests (https://www.iso.org/standard/41076.html)

ISO 15883-5:2021: Washer-disinfectors – Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy (https://www.iso.org/standard/68297.html)

ASTM F3208-20: Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices (https://www.astm.org/f3208-20.html)

ASTM F3293-18: Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices (https://www.astm.org/f3293-18.html)

There are many additional standards that manufacturers will need to refer to in addition to the ones listed above. Contact us at contact@alceonconsulting.com for additional information or service inquiry. Thank you!

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Cleaning Validation – How to select the worst case? appeared first on Medical Device made Easy Podcast. hamza benafqir

Medical Device News June 2024 Regulatory Update

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 06 Jun 2024 01:48:33 +0000

EUROPE
- EU MDR 26 May 2024 – Was there any apocalypse:
  - France: https://ansm.sante.fr/actualites/reglement-europeen-relatif-aux-dispositifs-medicaux-fin-de-la-periode-de-transition
  - Netherland: https://www.igj.nl/zorgsectoren/medische-technologie/nieuws/2024/05/23/fabrikanten-van-medische-hulpmiddelen-moeten-uiterlijk-26-mei-een-aanvraag-hebben-ingediend-voor-ce-certificering
- EU shortage managed – EUDAMED and IVD extension also discussed: https://www.consilium.europa.eu/en/press/press-releases/2024/05/30/medical-devices-council-adopts-new-measures-to-help-prevent-shortages/?utm_source=brevo&utm_campaign=AUTOMATED%20-%20Alert%20-%20Newsletter&utm_medium=email&utm_id=320
- EMA Q&A on Combination products – Do you need a Notified Body? https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/questions-answers-implementation-medical-devices-vitro-diagnostic-medical-devices-regulations-eu-2017-745-eu-2017-746_en.pdf
- EU talks about SoHo -: Substances of Human Origin
  - https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CONSIL:PE_8_2024_INIT&qid=1716536451356
  - https://www.consilium.europa.eu/en/press/press-releases/2024/05/27/council-adopts-new-rules-on-substances-of-human-origin/
- Italy Database error – Updating expired (AI)MDD certificates https://www.salute.gov.it/portale/news/p3_2_1_1_1.jsp?lingua=italiano&menu=notizie&p=dalministero&id=6569
- Ireland guide on In-House IVDs – Laboratories to listen: https://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/guide-for-health-institutions-who-manufacture-and-use-in-house-ivds-in-ireland-v1.pdf?sfvrsn=8
- Combined Studies in the EU – COMBINE PROJECT:
  - https://ec.europa.eu/newsroom/sante/items/830485/en
  - https://health.ec.europa.eu/document/download/77e1409a-f4c0-45db-bff1-4873c7a0e7ae_en?filename=md_combined-analysis-phase-report.pdf
Notified Bodies
- Survey Result: https://health.ec.europa.eu/document/download/59b9d90e-be42-4895-9f6f-bec35138bb0a_en?filename=md_nb_survey_certifications_applications_en.pdf
- Team-NB Survey: https://www.team-nb.org/wp-content/uploads/2024/05/Team-NB-MD-Sector-Survey-PressRelease-20240515.pdf
- New Notified Bodies for EU MDR –

UK
- UK on international recognition – Approve products without CE or UKCA mark:
  - https://www.gov.uk/government/news/mhra-announces-a-proposed-framework-for-international-recognition-of-medical-devices
  - https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices/statement-of-policy-intent-international-recognition-of-medical-devices
- UK implementation of Future Regulation – When will this come in force: https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices/implementation-of-the-future-regulations
- UK Common Specifications for IVD – Provide your opinion: https://www.gov.uk/government/consultations/common-specification-requirements-for-in-vitro-diagnostic-devices
- UK suspected counterfeit Medical Device – How to report: https://www.gov.uk/government/publications/report-a-non-compliant-medical-device-enforcement-process/report-a-non-compliant-or-suspected-counterfeit-medical-device
- UK Ai Airlock – Be ready to help the government: https://www.gov.uk/government/news/mhra-launches-ai-airlock-to-address-challenges-for-regulating-medical-devices-that-use-artificial-intelligence
  - Webinar planned July 23rd: https://www.eventbrite.co.uk/e/ai-airlock-the-regulatory-sandbox-for-aiamd-in-healthcare-webinar-tickets-896407919217

Easy Medical Device: eQMS SmartEye
- Video: One of the best eQMS for Medical Devices One of the best eQMS for Medical Devices

Events:
- Medtech Conf:
  - Title: International Medical Device Exhibition and Conference – Subtitle: Malaysia 10th to 12th December 2024 : https://medtechconf.com/event/imdec-2024-exhibition-conference/

Training
- Green Belt Training for EU MDR 2017/745 24th-28th June 2024: https://school.easymedicaldevice.com/gb/
- EU Vigilance Reporting: https://school.easymedicaldevice.com/course/vigilance-reporting-eu-legislation/
- Audit Readiness: https://school.easymedicaldevice.com/course/etraining-audit-readiness/

WORLD
- US
  - US Remanufacturing or Servicing – Webinar replay included:
    - https://www.fda.gov/media/150141/download
    - Webinar: https://www.fda.gov/medical-devices/medical-devices-news-and-events/webinar-final-guidance-remanufacturing-medical-devices-06272024
  - US – Use of Patient Generated Data – Medical Device Development: https://www.fda.gov/medical-devices/medical-devices-news-and-events/co-sponsored-public-workshop-using-patient-generated-health-data-medical-device-development-case
  - US Laboratory Developed Tests – Final rules defined and Webinar to explain:
- Australia
  - Australia – in-house IVDs requirements – Support Australian Laboratories: https://www.tga.gov.au/resources/resource/guidance/regulatory-requirements-house-ivds
  - Australia on boundary and Combination products List: https://www.tga.gov.au/sites/default/files/2024-05/examples-boundary-combination-products-and-product-category.pdf
- Saudi Arabia
  - Saudi Arabia – Webinar Biological Evaluation – 6 June 2024 10am Saudi Time https://www.sfda.gov.sa/en/workshop/716404
- Nigeria
  - Guidance to register Medical Devices – Registration, labelling and advertising:
- India
  - CDSCO laboratory testing – But in the Country and not outside: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTEzMTg=
- Malaysia
  - Malaysia Guidance for Medical Device – Change Notification support: https://www.mda.gov.my/index.php/announcement/1401-public-comment-draft-guidance-document-change-notification-for-registered-medical-device
- Hong-Kong
  - Overview of a Local Responsible Person – Who? What? When? Where?: https://www.mdd.gov.hk/filemanager/common/mdacs/GN-01-E.pdf
- Singapore
  - Singapore Cybersecurity labelling- SAt which level is your product: https://www.csa.gov.sg/our-programmes/certification-and-labelling-schemes/cls-md

PODCAST
- Podcast Nostalgia – What topics were discussed
  - Episode 283: Quality Field Service for Medical Devices with Michael Israel: https://podcast.easymedicaldevice.com/283-2/
  - Episode 284: How to select and evaluate your Contract Manufacturer with Keith Smith: https://podcast.easymedicaldevice.com/284-2/
  - Episode 285: Are you Correction or Corrective Action or Preventive Action with Vincent Cafiso: https://podcast.easymedicaldevice.com/285-2/
  - Episode 286: Summative Evaluation – Common Mistakes with Amandine Broussier: https://podcast.easymedicaldevice.com/286-2/

The post Medical Device News June 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

Summative Evaluation – Common mistakes

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 28 May 2024 00:00:00 +0000

I am sure that when we talk about usability, you are not really sure what should be done. Usually we are also following a standard for that which is IEC 62366. On this episode, Amandine Broussier will specifically focus on one part of usability which is the Summative Evaluation. She will explain what this is and when it should be done. So listen to this to be an expert in Usability.

Who is Amandine Broussier

Amandine Broussier is an independent medical devices usability specialist who supports medical device manufacturers in their usability engineering process (EN 62366-1:2015). She has 8 years of experience in the usability engineering, working with around 30 manufacturers on different devices (hardware, software) (class II, class III and IVD).

Amandine can help you through all stages of the usability engineering process including auditing your current usability documentation with recommendations for improvement, identifying of use-related risks, writing the different documents required by the EN 62366-1 standard, and carrying out your formative and summative evaluations for CE marking and FDA approval. She also provides introductions to usability engineering for companies to help them understand the expectation of notified bodies with regards to usability standards.

Who is Monir El Azzouzi?

Link

Amandine Broussier Linkedin Profile: https://www.linkedin.com/in/amandine-broussier-888a41113/
IEC 62366-1 link: https://www.iso.org/fr/standard/63179.html
IEC 62366-1/A1 link: https://www.iso.org/fr/standard/73007.html
IEC 62366-2: https://www.iso.org/fr/standard/69126.html

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Summative Evaluation – Common mistakes appeared first on Medical Device made Easy Podcast. hamza benafqir

Are you more Corrections or Corrective Actions or Preventive Actions?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 21 May 2024 00:00:00 +0000

Do you have to manage complaints, CAPA, Non-conformances, audits, management reviews… for your company. Then you need to put in place actions. Today we will explain to you with Vincent Cafiso what are Correction, Corrective Actions and Preventive Actions.

Who is Vincent Cafiso

Named as one of MD+DI’s 24 Medtech Voices to Follow in 2024, Vincent Cafiso is a former U.S. FDA Investigator with 30-years of medical device and in vitro diagnostics (IVD) industry experience and is currently the Founder and Managing Consultant for his firm Practical Compliance Results. Vincent prepares his clients to be ready for their next FDA inspection and Notified Body audit consulting in the areas of compliance, quality assurance, and quality systems.

Who is Monir El Azzouzi?

Link:

Vincent Cafiso Linkedin Profile: https://www.linkedin.com/in/vincentcafiso/
CREO Consulting Website: https://creoconsulting.com/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Are you more Corrections or Corrective Actions or Preventive Actions? appeared first on Medical Device made Easy Podcast. hamza benafqir

How to select and evaluate your Contract Manufacturer?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 14 May 2024 00:00:00 +0000

Medical Device manufacturers can also involve third party companies to manufacture their devices. We call them Contract Manufacturers. But they are only your supplier and not the legal manufacturer of the product. So now the question is how to select them and also how to handle them. Let’s find that out with Keith Smith from Vonco

Who is Keith Smith?

Keith Smith is the President and CEO of Vonco Products. Keith has a passion for cultivating infectious energy, innovation, and creation. He generously contributes time and resources to entrepreneurial, education, athletic, and health endeavors. Prior to acquiring Vonco in December of 2012, he served as a General Manager of Carbonless Rolls and Security Papers for Appleton Papers, the largest division of a $1BN paper company. Keith holds a bachelor’s degree in industrial engineering as well as an MBA from Northern Illinois University and Lean and Six Sigma certifications from the University of Michigan.

Who is Monir El Azzouzi?

Link

Keith Smith Linkedin Profile: https://www.linkedin.com/in/keith-smith-725508b/
Keith Smith Website: https://keithsmith.io/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post How to select and evaluate your Contract Manufacturer? appeared first on Medical Device made Easy Podcast. hamza benafqir

Quality Field Service for Medical Devices

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 07 May 2024 00:00:00 +0000

Michael Israel from Zuper.co is helping us understand the world of Field Service and then we can understand better how some information collected by Field Service Engineer can help Quality Department to have a better operation. Collect machine performance, train technicians, identify issues.

Michael will also talk about Zuper which is a FSM software (Field Service Management) and can help you save time and collect the write information. So don’t hesitate to check his website.

Who is Michael Israel?

Michael Israel is Vice President of Community and a member of the executive leadership team at Zuper. Michael has worked in customer and field service for more than 40 years. He spent 20 years in his early career managing both domestic and international field service operations, including 12 years with IBM’s Field Engineering organization. Over the past three decades, he has held management and executive roles with major providers of CRM and Field Service software applications, including tenures with IFS, Oracle, and SAP.  

His broad experience includes marketing, selling, supporting, and implementing CRM and Field Service software applications. Michael also served as a Field Service analyst for Aberdeen Group, the Technology Services Industry Association (TSIA), Jolt Consulting, and the Service Council.

Who is Monir El Azzouzi?

Link

Michael Israel Linkedin Profile: https://www.linkedin.com/in/michaelisrael1/
Zuper Website: https://zuper.co

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Quality Field Service for Medical Devices appeared first on Medical Device made Easy Podcast. hamza benafqir

Medical Device NewsMAY 2024 Regulatory Update

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 02 May 2024 10:27:56 +0000

Notified Bodies
- TUV SUD Denmark under MDR –Welcome to the Brother or Sister: https://api.tech.ec.europa.eu/nando-prod/files?repo=nando&id=150a0abbc0d4397086d648963fc940a321e02c11&group=NOTIFICATION&download=true
- AFNOR 46th NB under MDR –Finally a second one for France: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications?organizationRefeCd=EPOS_43655&filter=notificationStatusId:1
MDCG 2024-4 Guidance–Safety reporting in Performance Studies or IVD: https://health.ec.europa.eu/document/download/5cc894e0-331d-4fa2-8ab3-cdd4437c48fc_en?filename=mdcg_2024-4_en.pdf
- Form: https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fhealth.ec.europa.eu%2Fdocument%2Fdownload%2F54cbbfd4-5808-4560-93ef-017f2a3b0f41_en%3Ffilename%3Dmdcg_2024-4_appendix_en.xlsm&wdOrigin=BROWSELINK
MDCG 2024-5 Guidance – SInvestigator’s Brochure for Clinical Investigation: https://health.ec.europa.eu/document/download/ee7ee8eb-841a-4085-a8dc-af6d55ebf1bd_en?filename=mdcg_2024-5_en.pdf
- Checklist 2024-5 https://health.ec.europa.eu/document/download/a387e3e7-65e3-4af5-bb98-2281949feded_en?filename=mdcg_2024-5-appendix-a_en.docx
Survey Article 17 – Reprocessing of single use devices: https://op.europa.eu/o/opportal-service/download-handler?identifier=35ea0c60-e82c-11ee-9ea8-01aa75ed71a1&format=pdf&language=en&productionSystem=cellar&part=

Team-NB: ESMINT initiative – Call for expert: https://www.team-nb.org/esmint-initiative/
Spain AEMPS Bulletin on Health Products – From Jan – March 2024: https://www.aemps.gob.es/informa/boletin-sobre-productos-sanitarios-enero-marzo-de-2024/#vigProdSan
Germany: Classification – Bfarm to help you classify your device: https://www.bfarm.de/DE/Medizinprodukte/Antraege-und-Meldungen/Antrag-auf-Klassifizierung/_artikel.html
Swiss: SaMD – information sheet to help Software companies: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw630_30_007d_mbmedizinprodukte-software.pdf.download.pdf/BW630_30_007e_MB%20Medical%20Device%20Software.pdf
Turkey: 26 May 2024 – Reminder of the May 26th, 2024 deadline for EU MDR https://titck.gov.tr/duyuru/imalatcisi-tarafindan-sure-uzatimindan-faydalanmayacak-urunlerin-uts-surecleri-24042024160706

Article to read

European Medical Writers Association – Focus on Translation: https://journal.emwa.org/media/5111/mew-331-final.pdf

Training

Training EU MDR – Green Belt Certification Program GB31 May 2024: https://school.easymedicaldevice.com/course/gb31/
Malaysia training – Calendar 2024: https://portal.mda.gov.my/index.php/doclink/mda-core-training-list-2024-latest-nur-izzati-adha-binti-zuman-mda-pdf/eyJ0eXAiOiJKV1QiLCJhbGciOiJIUzI1NiJ9.eyJzdWIiOiJtZGEtY29yZS10cmFpbmluZy1saXN0LTIwMjQtbGF0ZXN0LW51ci1penphdGktYWRoYS1iaW50aS16dW1hbi1tZGEtcGRmIiwiaWF0IjoxNzE0MDEwNjUyLCJleHAiOjE3MTQwOTcwNTJ9.1KCY_1RCNi1mnJSCP30llN8kaBvcBJU6G_JMpc-OttI
Team-NB training – IVDR technical Documentation July 3rd, 2024: https://www.team-nb.org/fourth-session-ivdr-technical-documentation-training-for-manufacturers/

Events

Events – Check Medtech Conf: https://MedtechConf.com

Rest of the world

South Korea: Certificate Check –Verifying authenticity of certificates issued by MDFS: https://emedi.mfds.go.kr/msismext/emd/uif/issuDocTruflsEngView.do
South Korea: IVD method –How to register IVD in South Korea: https://www.law.go.kr/%EB%B2%95%EB%A0%B9/%EC%B2%B4%EC%99%B8%EC%A7%84%EB%8B%A8%EC%9D%98%EB%A3%8C%EA%B8%B0%EA%B8%B0%EB%B2%95/(19695,20230816)
South Korea: UDI rules to follow –Same but not the same: https://www.mfds.go.kr/eng/brd/m_40/down.do?brd_id=eng0011&seq=72636&data_tp=A&file_seq=1

Mexico: Draft Mexican official standard –Labelling of Medical Devices: https://www.dof.gob.mx/nota_detalle.php?codigo=5724246&fecha=23/04/2024#gsc.tab=0

Australia: Consultation on IFU – Call for more flexibility: https://www.tga.gov.au/resources/consultation/consultation-availability-instructions-use-ifu-more-flexible-formats

Podcast

Radiation Sterilisation Master File – Adam Issacs Rae: https://podcast.easymedicaldevice.com/279-2/
What is the impact of AI Act on Medical Devices – Erik Vollebregt: https://podcast.easymedicaldevice.com/280-2/
Why and how to build your Quality Culture – Lesley Worthington: https://podcast.easymedicaldevice.com/281-2/

The post Medical Device NewsMAY 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

Why and how to build a Quality Culture?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 23 Apr 2024 00:00:00 +0000

A quality culture seem to be a nice to have. But after listening this podcast episode with Lesley Worthington, you will see that it is worth to build one. We will review the description of a quality culture and how to build it. But also if this is required by a regulation and how you can align it with your compliance duties. Check this and share it with your team.

Who is Lesley Worthington?

Lesley works with individuals and teams to fine-tune their Quality conversations, initiatives, and internal communications to create a better understanding of the role and concepts of quality assurance throughout their organization.

Through her leadership and executive coaching, she supports professionals as they work on improving their relationships and effectiveness in their roles allowing them to achieve their fullest potential, professionally, and empowering them to move their organizations toward a robust Quality Culture.

She runs a community, The Quality Network, which supports Quality professionals as they work on the skills that allow them to build a Quality Culture. The Quality Network is a place for learning, coaching, support, and networking and includes webinars, resources, a member platform, courses, and office hours. 

She combines 20 years of quality and regulatory experience in medical devices, in Canada, with thousands of hours of teaching and coaching to provide her clients with the skills, techniques, insights, and mindset that raise their confidence, take their communication skills to the next level, and allow them to have a positive impact in their organizations.

She’s got a Psychology Degree, a Law Degree, English as a Second Language Teaching Qualifications, and is a Certified Executive Coach.

Who is Monir El Azzouzi?

Monir El Azzouzi, a distinguished expert in the medical device sector, holds a Biomedical Engineering degree from ISIFC in France. With extensive experience at top-tier companies such as Bausch+Lomb, Aesculap, and Johnson & Johnson, Monir has a deep understanding of the industry’s challenges and opportunities. His commitment to enhancing industry standards and support led him to establish Easy Medical Device.

Easy Medical Device is an innovative company dedicated to enriching the medical device community through educational outreach such as podcasting, blogging, and video creation. The company also offers specialized training programs, notably the Green Belt Certificate for EU MDR, to elevate professional skills within the industry.

Beyond education, Easy Medical Device provides comprehensive consulting services, helping manufacturers navigate the complexities of CE Marking, FDA registration, clinical evaluation reports, internal audits, design and development, supplier reviews, eQMS implementation, and due diligence. Our expertise extends to acting as authorized representatives and importers in Europe, Switzerland, and the UK, facilitating smoother market entry for our clients.

Monir’s vision for Easy Medical Device is to establish it as the definitive one-stop shop for all services related to medical device manufacturers. We are committed to assisting you in introducing and advancing your projects with efficiency and compliance.

Do not hesitate to contact Monir El Azzouzi at Easy Medical Device to explore how we can support your medical device initiatives.

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Why and how to build a Quality Culture? appeared first on Medical Device made Easy Podcast. hamza benafqir

What is the impact of AI Act on Medical Devices?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 16 Apr 2024 00:00:00 +0000

The AI Act or Artificial Intelligence Act is now a reality. But what does it mean for the Medical Device industry and what should you do within your Quality or Regulatory affairs activities.

Erik Vollebregt, from Axon Lawyers will tell us what we should understand with this new legislation and what are the consequences for the Medical Device community.

Who is Erik Vollebregt?

Who is Monir El Azzouzi?

Link:

Erik Vollebregt Linkedin Profile: https://www.linkedin.com/in/erikvollebregt/
Axon Lawyers Website: https://www.axonlawyers.com/
Erik Blog: https://medicaldeviceslegal.com/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post What is the impact of AI Act on Medical Devices? appeared first on Medical Device made Easy Podcast. hamza benafqir

Radiation Sterilisation Master File (ISO 11137 & 11607)

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 09 Apr 2024 01:00:00 +0000

If your products need to be sterilized, then you will need to prove that the sterilization process is validated and continues to work all through the life to the product. So Adam Isaacs Rae will provide you with the information on Radiation Sterilization requirements. Standards, guidelines, pitfalls. All this will help you remain compliant.

Who is Adam Isaacs Rae?

Who is Monir El Azzouzi?

Link:

Adam Isaacs Rae linkedin Profile: https://www.linkedin.com/in/adam-isaacs-rae/
Template Radiation Sterilisation Master File: https://school.easymedicaldevice.com/product/radiation-sterilisation-master-file-template/
ISO 11137- Radiation standards : https://www.iso.org/standard/33952.html
ISO 11607 – Packaging of terminally sterilised products: https://www.iso.org/standard/70799.html
ISO 11737 – Bioburden: https://www.iso.org/standard/66451.html

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Radiation Sterilisation Master File (ISO 11137 & 11607) appeared first on Medical Device made Easy Podcast. hamza benafqir

Medical Device News April 2024 Regulatory Update

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 04 Apr 2024 00:00:00 +0000

Sponsor:

Medboard: https://www.medboard.com/

EU

MDR and IVDR national languages update – France accepts English
- MDR: https://health.ec.europa.eu/document/download/aa9760e3-c864-4173-8b16-d790dac66d74_en?filename=md_sector_lang-req-table-mdr.pdf
- IVDR: https://health.ec.europa.eu/document/download/1e312d8f-8b34-45da-a5fa-1918ba618aca_en?filename=md_sector_lang-req-table-ivdr.pdf
Which devices for Expert Panel – Active Implantable Device on Top: https://health.ec.europa.eu/document/download/4c43abea-b989-434b-9ac1-94134bf1a538_en?filename=md_annual-overview-cecp-2022-2023_en.pdf
- 94.4% for Class III implantable and 5.6% for Class Iib Administer or remove medicinal products
- On Class III implantable – Top is with Active Implantable Devices
- Exempt devices are mainly within 3 categories (Main reason: Modification of a device already marketed):
  - Vascular and cardiac prostheses
  - Orthopaedic prostheses, osteosynthesis devices, devices for tendon and ligaments synthesis
  - Implantable prosthetic and osteosynthesis devices
Annex XVI: Is Brain Stimulation device risk? – SCHEER should evaluate by End 2025: https://health.ec.europa.eu/document/download/e6de1e88-2821-48f6-98f9-a56ea61cbfad_en?filename=scheer_q_031.pdf
- SCHEER = Scientific Committee on Health, Environmental and Emerging Risks
SCHEER on Phtalate – Update of the guidelines: https://health.ec.europa.eu/consultations/scheer-public-consultation-preliminary-update-scheer-guidelines-benefit-risk-assessment-presence_en
- Consultation until April 28th, 2024
MDCG subgroup Agenda – What is coming?: https://health.ec.europa.eu/document/download/f588a5c8-57af-48aa-808f-1d9c02f4925a_en?filename=mdcg_ongoing-guidance_0.pdf
MDCG 2024-3 on CIP – Clinical Investigation: https://health.ec.europa.eu/document/download/690de85a-ac17-45ea-bb32-7839540c25c4_en?filename=mdcg_2024-3_en.pdf
New Notified Body RISE Sweden – Welcome to the team 3033: https://api.tech.ec.europa.eu/nando-prod/files?repo=nando&id=d37c034bc695d2e143b5145b4cb7cd73caf8983c&group=NOTIFICATION&download=true
- 44 MDR NB
- 12 IVDR NB

UK

MHRA: Electrical Devices in Clinical Trials – Advice on application with separate document: https://assets.publishing.service.gov.uk/media/65fb0d66aa9b76001dfbdc28/MHRA_Electrical_Guidance_for_Clinical_Investigations_Modified_12_Feb.pdf

Ireland

HPRA Newsletter- IVD, Eudamed, Custom-made, Clinical trials: https://www.hpra.ie/docs/default-source/publications-forms/newsletters/hpra-medical-devices-newsletter-issue-57-february-2024.pdf

Turkey

Reminder on MDR transition period – May 26th, 2024: https://titck.gov.tr/storage/Archive/2024/announcement/duyurumetni_67231ed0-2553-4708-8231-7951c767e066.pdf
- Turkey strongly inform the different parties regarding MDR transition

Events

RAPS Euro Convergence – May 6-8 in Berlin-Germany: https://www.raps.org/europe-2024/home
Medtech Conf Map: https://medtechconf.com/event/connect-with-european-andinternational-regulatoryaffairs-peers-in-berlin-2/

Services

Packaging for Medical and Pharmaceutical – Design, Manufacturing and delivery: https://easymedicaldevice.com/packaging-for-medical-devices/

ROW

USA

Ban devices – Electrical Stimulation Devices for Self-injurious or Aggressive Behavior: https://www.fda.gov/medical-devices/medical-device-safety/medical-device-bans
- CNN article: https://edition.cnn.com/2024/03/25/health/fda-ban-electrical-stimulation-devices/index.html
- Comments open until May 28, 2024: https://www.fda.gov/medical-devices/medical-devices-news-and-events/fda-proposes-new-ban-electrical-stimulation-devices-self-injurious-or-aggressive-behavior
- Bans
  - Prosthetic Hair Fibers since 1983
  - Powdered Surgeon’s Gloves since 2017
  - Electrical Stimulation Devices for Self-injurious or Aggressive Behavior since March 2024
Animal Studie for Dental Bone Grafting devices – Choose the right animal Model: https://www.fda.gov/media/177340/download
- Minimum of 3 animals
- Animal Model: Canine and Porcine model instead of rodents
FDA: Deviations on Neuralink lab – Animal Study good practices: https://www.reuters.com/business/healthcare-pharmaceuticals/fda-finds-problems-animal-lab-run-by-musks-brain-implant-company-2024-02-29/
- Calibration of equipment’s are not done
- Quality officials not signing documents

Australia

Vigilance Reporting in Australia – For Recall and non-Recall: https://www.tga.gov.au/sites/default/files/2024-03/uniform-recall-procedure-therapeutic-goods-urptg.pdf
- Recall action Template: https://www.tga.gov.au/resources/resource/forms/recall-action-templates

Saudi Arabia

Guidance on Surgical Sutures – This contains some cheat code: https://www.sfda.gov.sa/sites/default/files/2024-03/%28MDS-G021%29En.pdf
- Endpoints that should be addressed
- Laboratories should be ISO/IEC 17025
- Shelf life should follow ASTM F1980

Brazil

MOU between Brazil and Paraguay – Memorandum of Understanding: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2024/anvisa-e-agencia-reguladora-do-paraguai-assinam-primeiro-memorando-de-entendimento
- Bilateral cooperation on health surveillance
- Strenghtening regulatory capacity
GMP validity from two to four years – If certified through MDSAP: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2024/anvisa-amplia-para-quatro-anos-prazo-de-validade-do-certificado-de-boas-praticas-de-fabricacao
Prioritize registration of Dengue Diagnosis Devices – Submit Now: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2024/anvisa-prioriza-registro-de-dispositivos-para-diagnostico-da-dengue
- Combat dengue epidemic as a matter of urgency

India

CDSCO: PSUR through online portal – From April 1st, 2024: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTEwMTI=
- Online portal: https://www.cdscomdonline.gov.in/NewMedDev/Homepage

Malaysia

Malaysia Faster approval – Establishment license application: https://www.mda.gov.my/index.php/announcement/1377-faster-approval-for-establishment-license-application-complete-applications-processed-within-14-21-working-days
- 14 to 21 Working days from date of application
- List of documents within the link

China

China Guidelines on registration – Specific products: https://www.cmde.org.cn/xwdt/zxyw/20240318133300123.html
- Corneal Topograph
- Laparoscopic surgery system
- Optical Radiation Safety device
- Monkeypox virus nucleid acid detections agent: https://www.cmde.org.cn/xwdt/zxyw/20240318111545184.html

Podcast

Podcast Nostalgia
- Episode 275 – FDA aligns QMSR with ISO 13485 (Naveen Agarwal): https://podcast.easymedicaldevice.com/275-2/
- Episode 276 – How to do Postmarketing Surveillance to right way? (Steve Curran): https://podcast.easymedicaldevice.com/276-2/
- Episode 277 – How to benefit from Survey to build Clinical Evidence? (Cesare Magri): https://podcast.easymedicaldevice.com/277-2/

Easy Medical Device

info@easymedicaldevice.com

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Medical Device News April 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

How to benefit from Surveys to build Clinical Evidence?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 26 Mar 2024 00:00:00 +0000

Since EU MDR and IVDR launched, there is a phenomenon that raised which is the use of surveys to gather clinical data. So we wanted to share with you how to do this right and what you should be careful on. So listen to Cesare Magri from 4BetterDevices who will tell us more about surveys in the Medical Device field.

Who is Cesare Magri?

Cesare has a mixed Background: Physics and Neuroscience, PhD in Informatics. He worked as a biostatistician at Max Planck in Tübingen and started working with medical devices and clinical evaluations in 2013. He founded be-on-Clinical together with Stefan Bolleininger in 2020. And recently, created the CRO 4BetterDevices.

Who is Monir El Azzouzi?

Link:

Linkedin Post High Quality Survey: https://www.linkedin.com/posts/cesare-magri_mdr-ivdr-clinicalinvestigation-activity-7173590917466042368-cFdG/
Linkedin Post User Survey: https://www.linkedin.com/posts/cesare-magri_mdr-ivdr-survey-activity-7175785619837595648-aRxY

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post How to benefit from Surveys to build Clinical Evidence? appeared first on Medical Device made Easy Podcast. hamza benafqir

How to do Postmarketing Surveillance the right way?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 19 Mar 2024 00:00:00 +0000

The EU MDR and IVDR is a bit more demanding on Postmarketing Surveillance. In this episode we will explain to you from the eye of an auditor what they want to see and how you can avoid some mistakes that are always identified.

Who is Steve Curran?

Dr Steve Curran has over 20 years experience in the medical device industry both as an engineer and leader developing medical devices but also as a Notified Body regulator ensuring that devices are compliant when they reach the market.  He has a broad range of experience from general medical devices to orthopaedic and dental devices and combination devices incorporating drugs and biologics.

Who is Monir El Azzouzi?

Link:

Steve’s LinkedIn: https://www.linkedin.com/in/stephencurran/
Blog on PMS: https://www.trinzo.com/medical-device-pms
PMS Training: https://www.meddevsolutions.co.uk/course/pms-training
Trinzo Website: www.trinzo.com
Trinzo LinkedIn: https://www.linkedin.com/company/trinzo

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post How to do Postmarketing Surveillance the right way? appeared first on Medical Device made Easy Podcast. hamza benafqir

Learn more about FDA QMSR alignment with ISO 13485

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 12 Mar 2024 00:00:00 +0000

The FDA announced the alignment of QMSR to the ISO 13485 standard. So now the question is: What does it change for me? Do you need to update your full QMS? Will you need to go through another audit or inspection? Is this really a revolution?

Naveen Agarwal from Exceed will answer this question. So don’t miss this episode to know more about QMSR.

Who is Naveen Agarwal?

Dr. Naveen Agarwal has 20+ years of diverse industry experience in leadership roles ranging from R&D to Product Quality and Business Analytics. He holds a Ph.D. in Polymer Science & Engineering from the University of Massachusetts, Amherst. He is an ASQ certified Quality Engineer, a Manager of Quality and Operational Excellence, and a certified Project Management Professional. In his consulting practice, he works on strategic projects in Risk Management, Design Control, Post-Market Surveillance, and Quality Culture in the Medical Device Industry. In his spare time, he enjoys distance running, community work, and spending time with his family.

Who is Monir El Azzouzi?

Link:

Naveen Agarwal Linkedin Profile: https://www.linkedin.com/in/naveenagarwal/
Learn more about Let’s Talk Risk! here ans subscribe: https://naveenagarwalphd.substack.com/about
Webinar recording – Getting Ready for QMSR: https://naveenagarwalphd.substack.com/p/webinar-5-getting-ready-for-qmsr
Risk management training on ACHIEVE: https://www.achievexl.com/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Learn more about FDA QMSR alignment with ISO 13485 appeared first on Medical Device made Easy Podcast. hamza benafqir

Medical Device News March 2024 Regulatory Update

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Wed, 06 Mar 2024 00:00:00 +0000

EU

EU proposal to prevent shortage – And other things: https://www.consilium.europa.eu/en/press/press-releases/2024/02/21/medical-devices-council-endorses-new-measures-to-help-prevent-shortages/
Notified Body Survey – Interesting statistics: https://health.ec.europa.eu/document/download/59b9d90e-be42-4895-9f6f-bec35138bb0a_en?filename=md_nb_survey_certifications_applications_en.pdf

Spain: AEMPS consultation – Qualification and Classification of Medical Devices: https://www.aemps.gob.es/informa/la-aemps-pone-en-marcha-un-procedimiento-para-consultas-relativas-a-la-cualificacion-y-clasificacion-de-productos-sanitarios-incluidos-los-de-diagnostico-in-vitro/
EURL Second Call – More Lab for High Risk IVD: https://health.ec.europa.eu/latest-updates/expression-interest-open-possible-second-call-eu-reference-laboratories-high-risk-vitro-diagnostic-2024-02-22_en
TEAM-NB Position Paper – Reclassification of IVD: https://www.team-nb.org/wp-content/uploads/2024/03/Team-NB-PositionPaper-Classification-of-SARS-Cov2-20240202.pdf
EMDN Proposal – Suggest your updates: https://webgate.ec.europa.eu/dyna2/emdn/
- MDCG 2024-2 : https://health.ec.europa.eu/document/download/de470384-e8be-45e7-a334-226757f8816d_en?filename=mdcg_2024-2_en.pdf
Does your product qualify for CECP -Notified Bodies should decide: https://www.ema.europa.eu/en/documents/other/working-instructions-notified-bodies-application-article-54-regulation-eu-2017-745-medical-devices-article-48-regulation-eu-2017-746-vitro-diagnostic-medical-devices_en.pdf

Training

Training Green Belt EU MDR – Learn by practicing: https://school.easymedicaldevice.com/course/gb30
- Open March 25th, 2024 until March 29th, 2024
TEAM-NB Training – Technical Documentation: https://www.team-nb.org/wp-content/uploads/2024/02/Leaflet-MDR-TD-Manufacturers-Training-20240429.pdf
- April 29th, 2024

Services

Packaging and IFU – Design and Production: https://easymedicaldevice.com/packaging-for-medical-devices/

ROW

USA

Fraudulent Lab -: FDA ask you to check your Third Party: https://www.fda.gov/medical-devices/industry-medical-devices/fraudulent-and-unreliable-laboratory-testing-data-premarket-submissions-fda-reminds-medical-device

CANADA

Consultation on Significant Changes -: Until April 22nd, 2024: https://www.canada.ca/en/health-canada/programs/draft-guidance-how-to-interpret-significant-change-medical-device.html
- Draft Guidance: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/interpret-significant-change-medical-device.html

Mexico

Mexico to Strengthen the Medical Device industry -: Harmonization planned with other Regulatory Pathways: https://www.gob.mx/cofepris/articulos/cofepris-presenta-agenda-de-fortalecimiento-de-la-industria-de-dispositivos-medicos?idiom=es

Saudi Arabia

SFDA Harmonized Standards – Which one is accepted?: https://www.sfda.gov.sa/sites/default/files/2024-02/MDS%E2%80%93G020.pdf

Qatar

Qatar Telemedicine – Policy to use this technology: https://www.moph.gov.qa/_layouts/15/download.aspx?SourceUrl=/Admin/Lists/Announcements%20Attachments/Attachments/275/Tele%20Policy.pdf

Australia

TGA SOPP requirements – System or Procedure Pack guidance: https://www.tga.gov.au/sites/default/files/2024-02/system-procedure-packs-guidance-sponsors-manufacturers-charities.pdf
TGA Essential Principles – Template available: https://www.tga.gov.au/sites/default/files/essential-principles-checklist-medical-devices.pdf
Transition to EU MDR cases – Evidence of transition, DCR, Non-Compliance, Recalls:

PODCAST

Episode 271 – How to get your interview prepared? With Elena Kyria https://podcast.easymedicaldevice.com/271-2/
Episode 272 – Will EtO gaz become a Medical Device? Christina Ziegenberg: https://podcast.easymedicaldevice.com/272-2/
Episode 272 – New EU Proposal, EUDAMED, Shortage and IVDR transition. Erik Vollebregt: https://podcast.easymedicaldevice.com/273-3/

EASY MEDICAL DEVICE Services:

Training: https://school.easymedicaldevice.com/emd-course/
Authorized Representative EU: https://easymedicaldevice.com/eu-rep/
Authorized Representative UK: https://easymedicaldevice.com/uk-responsible-person/
Authorized Representative Swiss: https://easymedicaldevice.com/swiss-authorised-representative/
Backoffice Services: https://easymedicaldevice.com/backoffice-service-medical-device/
Eqms SmartEye; https://smart-eye.io
Conferences: https://medtechconf.com/

The post Medical Device News March 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

New EU Proposal – EUDAMED, IVDR & Shortage

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 27 Feb 2024 01:00:00 +0000

In January 29^th, 2024, the EU Commission issued a Proposal that discuss mainly the shortage of Medical Devices, the EUDAMED availability and the IVDR transition periods. So apparently this is urgent and needed to avoid shortage. Let’s ask Erik Vollebregt what he thinks about it. Will this really help and when will this become a law as it is only a proposal for now.

Who is Erik Vollebregt?

Who is Monir El Azzouzi?

Link:

Erik Vollebregt Linkedin Profile: https://www.linkedin.com/in/erikvollebregt/
Axon Lawyers Website: https://www.axonlawyers.com/
Erik Blog: https://medicaldeviceslegal.com/
Linkedin post: https://www.linkedin.com/posts/erikvollebregt_medical-devices-council-endorses-new-measures-activity-7166021646573641730-abCh
Medical Devices: Council endorses new measures to help prevent shortage: https://www.consilium.europa.eu/en/press/press-releases/2024/02/21/medical-devices-council-endorses-new-measures-to-help-prevent-shortages/?utm_source=dsms-auto&utm_medium=email&utm_campaign=Medical+devices%3a+Council+endorses+new+measures+to+help+prevent+shortages
Proposal text: https://data.consilium.europa.eu/doc/document/ST-6156-2024-INIT/en/pdf

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post New EU Proposal – EUDAMED, IVDR & Shortage appeared first on Medical Device made Easy Podcast. hamza benafqir

Will EtO gaz become a Medical Device?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 20 Feb 2024 00:00:00 +0000

When you are willing to sterilise your Medical Devices, you maybe think of EtO or Ethylene Oxyd as the method. So if you are on that case, there is a potential change that will happen and we want to alert you about that.

Christina Ziegenberg from BVMed is answering my questions and will explain to us the situation. So don’t miss this episode.

Who is Christina Ziegenberg?

 Dr. Christina Ziegenberg can look back on a distinguished career in medical technology, the chemical industry and pharmacy. With an education at the HBLVA for Chemical Industry in Vienna, a diploma in pharmacy at the University of Vienna and a doctorate at the Private University of Liechtenstein (UFL), she has held management positions at Hilti Aktiengesellschaft, the Liechtenstein State Administration and most recently at BVMed, where she holds the position of Deputy Managing Director / Head of the Regulatory Affairs Department.

Who is Monir El Azzouzi?

Link

BVMed website: www.bvmed.de
BVMed link: https://www.bvmed.de/de/english/bvmed-services?pk_campaign=tsr_CHK&pk_kwd=english_tsr-aktuelles-gT_mi_bvmed-services
Current BVMed Position Paper in German: https://www.bvmed.de/download/positionspapier-ethylenoxid
BVMed Position Paper with regards to the public consultation: https://www.bvmed.de/download/bvmed-positionspapier-ethylenoxid-einstufung-nach-biozidverordnung-bpr
Information regarding EtO from ECHA: https://echa.europa.eu/de/information-on-chemicals/biocidal-active-substances/-/disas/factsheet/1304/PT02
Assessment report: https://echa.europa.eu/documents/10162/3e7d946a-6939-2f2e-252e-dcd03d9ea36e
BPC Opinion: https://echa.europa.eu/documents/10162/5a3831c0-e6d4-7140-1e1b-2c8e3369edd4

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Will EtO gaz become a Medical Device? appeared first on Medical Device made Easy Podcast. hamza benafqir

How to get your interview prepared?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 13 Feb 2024 00:00:00 +0000

You are maybe about to take a new job and you find out this episode of the podcast on how to prepare for an interview. I must say that we have invited the expert in recruitment for Medical Devices Elena Kyria from Elemed.

She will give you all the hints, tips to make your interview a success. So don’t miss this episode and don’t forget to raise your comments on the show notes.

Who is Elena Kyria?

Elena Kyria is an award winning talent acquisition specialist, and CEO of Elemed. Elemed helps companies hire exceptional talent, and helps top QA/RA talent reach brilliant companies. She also coaches and supports top talent on how to build a strong professional brand, to help maximise career possibilities, and leads an executive podcast “career diaries in medtech” designed to inspire the next generation of medtech professionals

Who is Monir El Azzouzi?

Link:

Elena Kyria LinkedIn Page: https://www.linkedin.com/in/elenakyria/
Elemed Website: https://www.elemed.eu/
Linkedin Post: https://www.linkedin.com/posts/elenakyria_pushpull-factors-job-interviews-activity-7161295184008257536-w-ub
Elemed Linkedin page:https://www.linkedin.com/company/elemed/
Youtube: https://www.youtube.com/channel/UCZmfrYKQd8T7EpJ96zLbkRg
Career Diaries by Elemed: https://elemed.buzzsprout.com/
Elemed tiktok: https://www.tiktok.com/@elemedteam
Elemed Instagram: https://www.instagram.com/elemedteam/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post How to get your interview prepared? appeared first on Medical Device made Easy Podcast. hamza benafqir

Medical Device News february 2024 Regulatory Update

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Wed, 07 Feb 2024 09:15:33 +0000

EU

Transition to the IVDR and EUDAMED Roll Out -An extension? Never !!!!!: https://health.ec.europa.eu/system/files/2024-01/mdr_in-vitro-proposal.PDF
MDCG 2024-1 Vigilance System for CE – Guidance and Template: https://health.ec.europa.eu/system/files/2024-01/mdcg_2024-1_en.pdf
- MDCG 2024-1-1 Device for Cardiac Ablation: https://health.ec.europa.eu/system/files/2024-01/mdcg_2024-1-1_en.pdf
- MDCG 2024-1-2 Coronary Stents and associated delivery systems: https://health.ec.europa.eu/system/files/2024-01/mdcg_2024-1-2_en.pdf
- MDCG 2024-1-3 Cardiac Implantable Electronic Devices (CIEDs): https://health.ec.europa.eu/system/files/2024-01/mdcg_2024-1-3_en.pdf
- MDCG 2024-1-4 Breast Implants: https://health.ec.europa.eu/system/files/2024-01/mdcg_2024-1-4_en.pdf
Language requirements for Manufacturers (MDR & IVDR) – Check where English is not applicable:
- MDR: https://health.ec.europa.eu/system/files/2024-01/md_sector_lang-req-table-mdr.pdf
- IVDR: https://health.ec.europa.eu/system/files/2024-01/md_sector_lang-req-table-ivdr.pdf

eQMS

your eQMS SmartEye – The best eQMS ever: https://eqms-smarteye.com

UK

Future Regulation roadmap – We still have to wait: https://assets.publishing.service.gov.uk/media/659d3539aaae22001356dc3c/Roadmap_towards_the_future_regulatory_framework_for_medical_devices__Jan_24.pdf

Course

Training EU MDR Green Belt – February and March 2024 : https://school.easymedicaldevice.com/gb/

Notified Bodies and Approved Bodies

UK Approved bodies – They are 9 now: https://www.gov.uk/government/news/mhra-announces-two-new-uk-approved-bodies-to-certify-medical-devices
- LNE-GMED: https://assets.publishing.service.gov.uk/media/65b799f2a0ae1b000d52616e/LNE-GMED_Scope_Medical_Devices.pdf
- Scarlet NB UK: https://assets.publishing.service.gov.uk/media/65b79a11a0ae1b000d52616f/AB_Scarlet_Scope_Jan_2024.pdf

GDP video

Good Documentation Practices – Check how to be sure to have good documents: https://www.youtube.com/watch?v=nkBpef5AstI

ROW

USA
- US FDA Quality Management System Regulation – Alignment to ISO 13485: https://www.fda.gov/medical-devices/quality-system-qs-regulationmedical-device-current-good-manufacturing-practices-cgmp/quality-management-system-regulation-final-rule-amending-quality-system-regulation-frequently-asked
- US FDA IVD Reclassification – Move from Class III to Class II: https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrh-announces-intent-initiate-reclassification-process-most-high-risk-ivds
- FDA Remote Regulatory Assessment (RRA) – Question and Answers: https://www.fda.gov/media/160173/download
- Estar 5.1 version -: IVD and non-IVD: https://www.fda.gov/medical-devices/how-study-and-market-your-device/estar-program
  - Non-IVD: https://www.fda.gov/media/174458/download?attachment
  - IVD: https://www.fda.gov/media/174459/download?attachment
  - eStar 5.0 video with Rob Packard: https://www.youtube.com/watch?v=KDkKnRnBfgc
Saudi Arabia
- Webinar: Artificial Intelligence and Software -:February 13th, 2024 at 10 AM Middle East time : https://www.sfda.gov.sa/en/workshop/93262
- Manufacturing Devices at Point of Care (PoC) – uidance on how to manufacture them: https://www.sfda.gov.sa/sites/default/files/2024-01/MDS%20–%20G009E.pdf

Events

Medtech Conf – RAPS Workshop – Feb 27th until March 1st: https://medtechconf.com/event/raps-events/

Podcast Nostalgia – Relisten again and again

Episode 267 – Warning! Apply to your Notified Body Now! with Pritam Mekala: https://podcast.easymedicaldevice.com/267-2/
Episode 268 – You are not the Physical Manufacturer, can you be MDR certified: https://podcast.easymedicaldevice.com/268-2/
Episode 269 – Why you should use Pre-Submission or Q-Sub with FDA: https://podcast.easymedicaldevice.com/269-2/

Whatsapp Community:

Whatsapp community – Register even if it says no: https://chat.whatsapp.com/DvpnuGLihD98zGXsiYicQq

The post Medical Device News february 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

Why you should use Pre-Submission or Q-Sub with FDA?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 30 Jan 2024 00:00:00 +0000

We always have a problem to contact regulators to ask them if our strategy is correct. In Europe, you cannot do that with a Notified Body unless you apply with one first and they cannot provide you with advice but just agree or disagree on your plan. Is it the same with the FDA. They have a specific pathway called Q-sub or Pre-Submission and you’ll see that this may be your Superpower to accelerate your success with your FDA application. Let’s listen to Saad Attiyah who will explain what is Q-SUB.

Who is Saad Attiyah?

Experienced Regulatory Affairs and Quality Assurance professional with 20+ years of experience in medical devices, in-vitro diagnostics, human/cell tissue products, and combination device/drug products. Proven experience with U.S., Canadian, and E.U. Regulators, submissions, and Global Strategy Development. Extensive experience authoring U.S. 510(k)’s, E.U. MDR Technical Documentation, HDE Supplement, HDE/PMA Change Assessments for Supplements, Letters to File, Q-Submission, and Canadian New Submission/Amendments. Certified Lead Auditor, QMS Expert, and Warning Letter Remediation. 

Areas of specialty: New Product Development Strategy for Global Markets, Maintenance and remediation of existing devices, clinical evaluation reports/trials, and compliance activities, QA/QC, SOP development.

Device Types: Capital equipment and consumables such as blood analyzers and reagents, sterilizers and sterilant, ventilators, aspirators, centrifuges, implantable devices, single use medical devices, reusable instruments, and thermometry devices.

Device Classifications: US I through III, Canada Class II through IV, E.U. Class I through Class III, Compassionate Use

510(k): K072866-Spinal Fixation System, K080281- Interbody Fusion Device, K090566- Novel Interbody Fusion Device, K091134- Anterior Cervical Plating, K092904 -Vertebral Body Replacement Device, K111009- Spinal Fixation System, K111774- Interbody Fusion Device, K153379- Orthopedic Plating, K161863- Shoulder Arthroplasty Devices w/expanded indications, K181091- Orthopedic Plating w/ Pediatric Indications.

Who is Monir El Azzouzi?

Link:

Saad Attiyah LinkedIn: https://www.linkedin.com/in/saadattiyah
US FDA QSUB guidance : https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-medical-device-submissions-q-submission-program

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Why you should use Pre-Submission or Q-Sub with FDA? appeared first on Medical Device made Easy Podcast. hamza benafqir

You are not the Physical Manufacturer, can you be MDR certified?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 23 Jan 2024 00:00:00 +0000

Who is Adam Isaacs Rae?

Who is Monir El Azzouzi?

Links from the Video:

Profile LinkedIn: https://wwwhttps://www.linkedin.com/in/adam-isaacs-rae/.linkedin.com/in/
Useful Documents: https://www.gov.uk/government/publications/medical-devices-virtual-manufacturing-replaces-own-brand-labelling/virtual-manufacturing-of-medical-devices
Virtual Manufacturer : Commission Recommendation 2013/473/EC. https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2013:253:0027:0035:EN:PDF

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post You are not the Physical Manufacturer, can you be MDR certified? appeared first on Medical Device made Easy Podcast. hamza benafqir

MEDICA 2023 – InterviewS with Startups, Service Providers, Notified Bodies…

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 18 Jan 2024 10:02:29 +0000

Medica 2023 was really a great event and I am please to provide you here with a summary and interviews with multiple actors. You’ll see that this is so diverse. We met with Startups, Service Providers, Notified Bodies and asked them the questions you would like to ask. So don’t miss this opportunity first to understand what is MEDICA and second to hear what Notified Bodies are saying for example.

Who is Monir El Azzouzi?

Links from the Video

linkedin Abhinav Jain: https://www.linkedin.com/in/4abhinavjain/ linkedin Diego
linkedin Stevanella:https://www.linkedin.com/in/diego-stevanella-25605310b
linkedin Anindya Mookerjea: https://www.linkedin.com/in/anindyamookerjea
linkedin Alessia Frabetti : https://www.linkedin.com/in/alessia-frabetti-6746465b/
linkedin ADNAN ASHFAQ :https://www.linkedin.com/in/adnan-ashfaq-44478121/
linkedin Stuart Angell: https://www.linkedin.com/in/stuartangellivd/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post MEDICA 2023 – InterviewS with Startups, Service Providers, Notified Bodies… appeared first on Medical Device made Easy Podcast. hamza benafqir

WARNING! APPLY TO YOUR NOTIFIED BODY NOW!

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 16 Jan 2024 00:00:00 +0000

The EU MDR 2017/745 was extended but does this change something for you? Do you need to apply to your notified body later? What can be the promise made by your Notified Body? Can they advice you? Pritam from TÜV SÜD will be answering my question without any taboo. So don’t hesitate also to go to the show notes and see his details as at the end of the video he will be making you a promise. So don’t miss this opportunity.

And if you need some support for your Notified Body application contact us at Easy Medical Device.

Who is Monir El Azzouzi?

Who is Pritam Mekala?

Pritam Mekala is an enthusiastic, ambitious, and motivated medical device expert. Born in India, grew up in America, studied in the US, and currently living and working in Toronto, Canada, Pritam is an ensemble of multi-national, multi-cultural and multi-linguistic personality. He currently works at TÜV SÜD, as a Product Expert & Auditor in their Medical Health Sciences (MHS) Product Assessment Team (PAT).

Before joining the Notified Body team, Pritam worked as a was project engineer at Abbott on their infamous BinaxNOW – COVID Test Kit project. He also worked at other notable medical device manufacturers such as Medtronic, Covidien, Zimmer Biomet etc.

On the education front, Pritam graduated from the Oklahoma State University with a master’s in mechanical and aerospace engineering with research & specialization in Biomedical Engineering.

As a representative of Notified Body, TÜV SÜD, Pritam can help you facilitate:

Free 30minute Call (at no additional cost) *NOT CONSULTATION*
Free Budgetary quote (for review & comparison)
Free Technical Documentation Guidance (at no additional cost)

Links from the Video

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post WARNING! APPLY TO YOUR NOTIFIED BODY NOW! appeared first on Medical Device made Easy Podcast. hamza benafqir

Medical Device News – january 2024 Regulatory Update

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Wed, 10 Jan 2024 00:00:00 +0000

Medboard

Who is Medboard

Medboard: https://www.medboard.com/

EU Reference laboratories EURL

EU Reference laboratories for IVD products: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202302713
- Article : https://health.ec.europa.eu/latest-updates/designation-eu-reference-laboratories-high-risk-vitro-diagnostic-medical-devices-2023-12-06_en

Letter to EU Parliament

Letter sent to the European Parliament – Cybersecurity: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CONSIL:ST_17000_2023_INIT

MDCG 2023-7 on Clinical Investigation

MDCG 2023-7 Guidance on exemptions from the requirements to perform clinical investigations pursuant to Article 61(4)-(6) MDR: https://health.ec.europa.eu/document/download/1b5f9cc0-cea0-4459-921f-eaf4b4f80983_en?filename=mdcg_2023-7_en.pdf

MDCG 2019-07 rev 1 on PRRC

MDCG 2019-07 Rev 1: Guidance on Article 15 of MDR and IVDR on PRRC: https://health.ec.europa.eu/system/files/2023-12/md_mdcg_2019_7_guidance_art15_mdr_ivdr_en.pdf

MDCG 2021-27 on Importer and Distributor

MDCG 2021-27 Rev 1 Q&A Article 13 & 14 MDR and IVDR: https://health.ec.europa.eu/system/files/2023-12/mdcg_2021-27_en.pdf

MDCG 2023-5 on Annex XVI class

MDCG 2023-5 Guidance on qualification and classification of Annex XVI products: https://health.ec.europa.eu/system/files/2023-12/mdcg_2023-5_en.pdf

MDCG 2023-6 on Annex XVI Equivalency

MDCG 2023-6 Guidance on demonstration of equivalence for Annex XVI products: https://health.ec.europa.eu/system/files/2023-12/mdcg_2023-6_en.pdf

Companion Diagnostics CDx

EMA Q&A on Companion Diagnostics CDx: https://www.ema.europa.eu/en/documents/other/frequently-asked-questions-medicinal-products-development-and-assessment-involving-companion-diagnostic-cdx_en.pdf

Switzerland

Guidance on Devices with no medical purpose

Medical Device without Medical Intended Purpose: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/mu600_00_007d_mb_produkte_ohne_medizinische_zweckbestimmung.pdf.download.pdf/MU600_00_007e_MB_Devices_without_an_intended_medical_purpose.pdf

Emergency use of non-conform device

Exemption to Medical Device non-conforming: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw617_00_003d_mb-ausnahmebewilligung-mep.pdf.download.pdf/BW617_00_003e_MB%20Derogation%20MEP.pdf

Notified Bodies:

New Notified Body under EU MDR

43rd NB MDR – CESKY METROLOGICKY INSTITUT – Czech Republic: https://api.tech.ec.europa.eu/nando-prod/files?repo=nando&id=17f0c069619116060627ac0f430dff1c8cbc295c&group=NOTIFICATION&download=true

Notified Body Situation

Notified Body Situation; https://health.ec.europa.eu/system/files/2023-12/notifiedbodies_overview_en.pdf

Training:

EU MDR training

Green Belt training
- 28th edition January 22nd until 28th https://school.easymedicaldevice.com/course/gb28/
- 29th edition February 19th until 23rd https://school.easymedicaldevice.com/course/gb29/
- 30th edition March 25th until 29th https://school.easymedicaldevice.com/course/gb30/

Medical Device e-Training

eTraining
- Vigilance Reporting: https://school.easymedicaldevice.com/course/vigilance-reporting-eu-legislation/
- Audit Readiness: https://school.easymedicaldevice.com/course/etraining-audit-readiness/

ROW

Mexico:
Mexico registration rules

Guide for obtaining the Health Registry of Medical Devices – https://app.medboard.com/your-medboard/systematic-reviews/authorities-news/2243/

Brazil:
Brazil is calling Innovative Medical Devices
- Innovative Medical Devices: Anvisa extends deadline for participation in pilot project: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2024/dispositivos-medicos-inovadores-anvisa-prorroga-prazo-de-participacao-em-projeto-piloto
Hong-Kong:
Hong-Kong Guidances
- Artificial Intelligence Medical Devices: https://www.mdd.gov.hk/filemanager/common/mdacs/TR008.pdf
- Software Medical Devices and Cybersecurity: https://www.mdd.gov.hk/filemanager/common/mdacs/TR007.pdf
- Guidance note for Listing Class II/III/IV General Medical Devices: https://www.mdd.gov.hk/filemanager/common/mdacs/GN-02-E.pdf
- Guidance note for Listing Class B, C, D In-Vitro Diagnostic Medical Devices: https://www.mdd.gov.hk/filemanager/common/mdacs/GN-06-E.pdf
- Classification of In-Vitro Diagnostic Medical Devices: https://www.mdd.gov.hk/filemanager/common/mdacs/TR006E.pdf
USA:
USA Export documents transition to digital
- Transition to Electronic Export Documents – Letter to Industry: https://www.fda.gov/medical-devices/industry-medical-devices/transition-electronic-export-documents-letter-industry
India:
India New platform to register
- National Single Window System (NSWS) Portal: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTA4MTA=
Australia:

Australia Boundary and Combination products

guide on boundary and combination products https://www.tga.gov.au/sites/default/files/2023-12/guidance-boundary-combination-products.pdf

Australia on Custom-Made and Patient Match
- How to submit a custom-made medical device / patient-matched medical device notification: https://www.tga.gov.au/sites/default/files/2023-12/How-submit-custom-made-medical-device-patient-matched-medical-device-notification-guide.pdf
Malaysia
Malaysia is telling rules on Borderline products
- Harmonised borderline products in ASEAN: https://www.mda.gov.my/index.php/doclink/guidance-document-harmonised-borderline-products-in-asean-second-edition-2-pdf/eyJ0eXAiOiJKV1QiLCJhbGciOiJIUzI1NiJ9.eyJzdWIiOiJndWlkYW5jZS1kb2N1bWVudC1oYXJtb25pc2VkLWJvcmRlcmxpbmUtcHJvZHVjdHMtaW4tYXNlYW4tc2Vjb25kLWVkaXRpb24tMi1wZGYiLCJpYXQiOjE3MDIzNDcxOTksImV4cCI6MTcwMjQzMzU5OX0.4cNrbv3GpbG2KjL6uQxcxm3KeBGLsxZy77JqQKiIXUc
Malaysia is telling rules for classification of products
- List of harmonized classification of Medical Devices in ASEAN: https://www.mda.gov.my/index.php/doclink/guidance-document-harmonised-classification-of-medical-device-in-asean-second-edition-2-pdf/eyJ0eXAiOiJKV1QiLCJhbGciOiJIUzI1NiJ9.eyJzdWIiOiJndWlkYW5jZS1kb2N1bWVudC1oYXJtb25pc2VkLWNsYXNzaWZpY2F0aW9uLW9mLW1lZGljYWwtZGV2aWNlLWluLWFzZWFuLXNlY29uZC1lZGl0aW9uLTItcGRmIiwiaWF0IjoxNzAyMzQ3MTk5LCJleHAiOjE3MDI0MzM1OTl9.WbMya1V8vykQ88aQyqpraMR4G7rZ_QA36hN_DOEeqso

Podcast Nostalgia

Podcast Nostalgia

Episode 262 – What is usability: https://podcast.easymedicaldevice.com/262-2/
Episode 263 – Why you should invest in your Regulatory Team: https://podcast.easymedicaldevice.com/263-2/
Episode 264 – Life of a QA RA Podcaster https://podcast.easymedicaldevice.com/264-2/
Episode 265 – Heatmap: https://podcast.easymedicaldevice.com/265-2/

The post Medical Device News – january 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

Regulatory Maturity Model – Heatmap (MEDICA 2023)

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 02 Jan 2024 00:00:00 +0000

This presentation was recorded during MEDICA COMPAMED 2023. Stefan Bolleininger from Be on Quality did share with us the information about HEATMAP for Regulatory Affairs. The idea is mainly to be able to improve the visualisation of a certain state of your department or project. There will be the collection of data, the scoring, then the creation of the heatmap, the colour coding, the visualization, and analysis/actions.

So, if you want to find a refreshing way to present the situation of your projects, don’t hesitate to learn this with this presentation. And download the presentation within the link below.

Who is Stefan Bolleininger?

Stefan Bolleininger is a key opinion leader and speaker for the medical device regulation MDR in Europe. He founded the be-on-Quality GmbH consulting agency to passionately support manufacturers during CE approvals or FDA approvals. This support covers the full chain of quality and regulatory requirements: Implementation, maintenance, audits, assessments, and inspections. In the area of “Risk Management and Usability for Medical Devices and Medical Networks”, he holds a teaching assignment at the the Technical University of Nuremberg and the VDI Technical Committee “Quality Assurance for Software in Medical Devices”.

Who is Monir El Azzouzi?

Link:

Stefan Bolleininger LinkedIn Page: https://www.linkedin.com/in/stefan-bolleininger-3a717028/
Be on quality website: http://www.be-on-quality.com/en/home-en/
Download presentation: https://mailchi.mp/easymedicaldevice/265-heatmap
Medica Website: https://www.medica-tradefair.com/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Regulatory Maturity Model – Heatmap (MEDICA 2023) appeared first on Medical Device made Easy Podcast. hamza benafqir

Life of QA RA Podcasters?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 26 Dec 2023 00:00:00 +0000

Easy Medical Device has its podcast and many other Quality and Regulatory Affairs people are also doing podcasting. I have met with Claudia and Jorg who are also having a podcast and we reviewed our experience and encouraged people to also start their podcast. Check our experience and learn from it.

Who is Monir El Azzouzi?

Link:

Claudia Dannehl Linkedin Profile: https://www.linkedin.com/in/claudia-dannehl/
Jorg Brokmann Linkedin Profile: https://www.linkedin.com/in/j%C3%B6rg-brokmann-051438249/
Podcast Spotify: https://open.spotify.com/show/1H9MS4y7RmDQsDxM4DfDow?si=3e6b684150c049d1

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Life of QA RA Podcasters? appeared first on Medical Device made Easy Podcast. hamza benafqir

Why should you invest in your Regulatory Team?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 18 Dec 2023 23:35:57 +0000

Regulatory affairs teams have an outsized impact on business revenue, bringing new products to market quickly, managing registrations and licenses to keep products on the market, and staying updated on changing standards and regulations that might impact market clearance. Yet most regulatory affairs teams are treated primarily as operational cost-centers, resulting in poor productivity measurement, unclear objectives, and limited investments in people and technology.  
 
During this podcast episode, we’ll discuss why medtech companies should invest in their regulatory teams

Who is James Gianoutsos?

James Gianoutsos is the Founder & CEO of Rimsys Regulatory Management Software, a cloud-based solution to digitize, automate, and create regulatory order for MedTech companies. James is a quality assurance and regulatory affairs professional who has a diverse background in the medical device, pharmaceutical and biologics industries. His professional experience includes the design, premarket approval, clinical trials, manufacturing, distribution and post-market surveillance of drug products and class I, II, and III devices. James also has extensive experience in establishing and maintaining quality management systems in accordance with FDA, ISO, cGMP, MDD, MDR, MDSAP, CMDCAS requirements and standards and has helped develop and submit multiple regulatory filings including Premarket Approvals (PMA), 510(k)s, Design Dossiers, Technical Files and INDs. James holds a Bachelor of Science in operations management as well as a Master of Business Administration (MBA) with a concentration in operations management and strategy from the University of Pittsburgh – Katz Graduate School of Business.

Who is Monir El Azzouzi?

Link

James Gianoutsos LinkedIn: https://www.linkedin.com/in/jwgianoutsos/
Rimsys website: https://www.rimsys.io/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Why should you invest in your Regulatory Team? appeared first on Medical Device made Easy Podcast. hamza benafqir

What is Usability for Medical Devices?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 12 Dec 2023 00:00:00 +0000

The Medical Device field is so big that we have a specialist for each type of area. This is like a Surgeon that is specialist of the heart, the orthopaedic… Here we have with us a specialist for Usability, and this is really a big filed that you need to understand. IEC 62366 is a standard that is important to know as all devices that have a user interface should show they can be safe, and that user understands it. So, don’t miss this episode.

Who is Michael Engler?

Senior Consultant, Managing Partner at Benkana Interfaces GmbH & Co. K

Who is Monir El Azzouzi?

Link:

Michael Engler LinkedIn Page: https://www.linkedin.com/in/michael-engler-benkana/

Benkana Interface website: https://www.benkana-interfaces.com/

The post What is Usability for Medical Devices? appeared first on Medical Device made Easy Podcast. hamza benafqir

Medical Device News: December 2023 Regulatory Update

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 05 Dec 2023 00:00:00 +0000

Medboard

Medboard platform Sponsor of the podcast https://www.medboard.com/

EU

EPSCO Meeting November 30th. 2023 – MDR IVDR device risk of disruption: https://data.consilium.europa.eu/doc/document/ST-15385-2023-REV-2/x/pdf
Survey on Medical Devices – Study supporting the monitoring of the availability of Medical Devices on the EU Market.
- Information: https://ec.europa.eu/eusurvey/runner/MFandAR
- Questionary: https://ec.europa.eu/eusurvey/files/6a4fd4cd-dfce-4fe1-bcaf-9f44eb00e471/650fed06-30d2-40b1-9ff0-e96c79b4eb96
Falsification of Medical Devices – Survey result: https://act.edqm.eu/s/XcPw5MDtYe49gmj/download/CMED-Survey-Report-Final%20%281%29.pdf
MDCG 2022-11 Rev 1 Position Paper – Call to NB to streamline the certification process https://health.ec.europa.eu/system/files/2023-11/mdcg_2022-11_en.pdf
EU IVDR Technical Documentation training – TEAM-NB Survey result
- Training IVDR technical documentation February 1st, 2024: https://www.team-nb.org/wp-content/uploads/2023/11/Leaflet-IVD-TD-Manufacturers-Training-20240201.pdf
- Result on Survey of MDR training: https://www.team-nb.org/mdr-technical-documentation-training-for-manufacturers/

DEHP Substance forbidden in Medical Devices – Extension to July 1st, 2030 : https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202302482
Notified Bodies Situation – 2 new comers:
- UDEM Turkey 41st NB under MDR: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications/1004365?organizationVersion=7
- Scarlett NB B.VC. 42nd NB under MDR: https://api.tech.ec.europa.eu/nando-prod/files?repo=nando&id=2feeb6d10d338167081ad0cf7af6683fe760cded&group=NOTIFICATION&download=true

Switzerland

Vigilance Reporting submission information – Update your QMS procedures: https://www.swissmedic.ch/swissmedic/de/home/medizinprodukte/uebersicht-medizinprodukte/archiv/hinweis-einreichung-vigilance-meldungen-mep.html

Training EU MDR

Training EU MDR 2017/745 – December 11th – Green Belt Certification Program for EU MDR : https://school.easymedicaldevice.com/course/gb27

Medtech Conf

Your Medtech Conferences – Register all your Events, Training, Conferences: https://medtechconf.com/

USA

FDA withdrawal – not anymore member of the GHWP: https://www.fda.gov/media/174142/download
Discontinuation in the USA – Notifying FDA of a permanent discontinuation: https://www.fda.gov/media/155245/download
Webinar on Companion Diagnostics – Oncology Drug Products used with IVD tests: https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-oncology-drug-products-used-certain-in-vitro-diagnostic-tests-pilot-program-12122023

Canada

Medical Device Establishment Licenses annual review – You should receive your Christmas Package: https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/medical-devices-compliance-bulletin/annual-licence-review-2024.html

Saudi Arabia

Webinar: Clinical Trials of Medical Device Requirements – Click on the link in December 12th, 2023: https://www.sfda.gov.sa/en/workshop/93098

South Africa

Guideline on Q&A for Licensing of Medical Device Establishment – Learn how to start this activity: https://www.sahpra.org.za/wp-content/uploads/2023/02/SAHPGL-MD-07_v3-Guideline-on-Questions-and-Answers-Licensing-of-Medical-Device-Establishments55.pdf

Brazil

Argentina & Brazil signed a Mutual Recognition Agreement – For certificates for Medical Devices: https://www.argentina.gob.ar/noticias/anmat-y-anvisa-firmaron-el-primer-acuerdo-de-reconocimiento-mutuo-en-certificados-para

SmartEye

eQMS for Medical Device companies – Get your Demo now: https://smart-eye.io

Podcast Nostalgia

How to CE certify a calculator, risk score software as Medical Device? Cesare Magri: https://podcast.easymedicaldevice.com/258-2/
How to find a predicate Device for your 510k submission? Beat Keller: https://podcast.easymedicaldevice.com/259-2/
What is the situation regarding Digitalization in the Medtech industry? MedXD https://podcast.easymedicaldevice.com/260-2/

Easy Medical Device support – info@easymedicaldevice.com

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Medical Device News: December 2023 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

What is the situation regarding digitalization in Medtech?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 28 Nov 2023 08:10:01 +0000

Don’t miss this panel discussion that happened during the MEDXD in Berlin (26 and 27 September). Medical Device companies are moving to digitalize their processes and MDKU association did create the MEDXD conference where the discussions from multiple companies helped to understand the status.

Monir El Azzouzi moderated this panel and asked questions following the presentation that were provided.

This panel discussion was composed of

Karim Djamshidi
1. Vice President Global Patient Health & regulatory Compliance, Karl Storz https://www.linkedin.com /in/karim-djamshidi/
Denise Wocko
- Head of Global Client Portfolio Management, RQM+
- https://www.linkedin.com/in/denisewocko/
Sarah Haake-Schäfer
- Head of Quality Management, Regulatory & Clinical Affairs, Carl Zeiss Vision https://www.linkedin.com/in/sarah-h-981a94226/
Markus Pöttker
- PMS Lead – Safety & Surveillance, Smith + Nephew, https://www.linkedin.com/in/markuspoettker/
Sarah Panten
- Managing Partner / Strategic Business & Product Development, avasis
- https://www.linkedin.com/in/sarahpanten/

Who is Monir El Azzouzi?

Link:

MEDXD link: https://medtechx.digital/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post What is the situation regarding digitalization in Medtech? appeared first on Medical Device made Easy Podcast. hamza benafqir

How to find your Predicate Device for your 510K Submission?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 21 Nov 2023 00:00:00 +0000

The choice of a Predicate Device is important and challenging at the same time. Your predicate device is already on the US market, so all you must do is select it and confirm that your device is the same as the predicate and Bingo, you can register your product in the US. But this is not as simple as that. Beat Keller from imt in Switzerland will share with us his experience working on US submissions and provide some hints on what you should or should not do.

Who is Beat Keller?

Beat is the Head of Regulatory Affairs and Quality Management at IMT, a Swiss Consultancy and Engineering Service provider for medical device manufacturers. He has worked for more than 10 years in the medical device industry first as a software engineer, then as a project leader before he took over the Regulatory and Quality department of IMT.

Beat is also active in different standards working group as Co-Convenor of the “conformity assessment” working group of the Swiss standards association and member of different working groups on Swiss, European and International level for medical device standards.

Who is Monir El Azzouzi?

Link:

Beat Keller LinkedIn: https://www.linkedin.com/in/beat-keller/
imt website: https://www.imt.ch/
US FDA predicate device guidance: https://www.fda.gov/media/171838/download
MDCG Guidance on Equivalent Devices: https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2020_5_guidance_clinical_evaluation_equivalence_en_0.pdf

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post How to find your Predicate Device for your 510K Submission? appeared first on Medical Device made Easy Podcast. hamza benafqir

How to CE certify a Calculator, Risk Score…?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 14 Nov 2023 00:00:00 +0000

We have a lot of sort of Software as Medical Devices. Today I wanted to ask to Cesare Magri some questions about APIs. First what they are, and can they be a Medical Device. He will also give us some advice on what to do if your API is really a medical device. So stay tuned.

Who is Cesare Magri?

Who is Monir El Azzouzi?

Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.

Links from the Video

■ Cesare Magri LinkedIn: https://www.linkedin.com/in/cesare-magri/
■ 4BetterDevices website: https://4betterdevices.com/

Social Media to follow

■ Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
■ Twitter: https://twitter.com/elazzouzim
■ Pinterest: https://www.pinterest.com/easymedicaldevice
■ Instagram: https://www.instagram.com/easymedicaldevice

The post How to CE certify a Calculator, Risk Score…? appeared first on Medical Device made Easy Podcast. hamza benafqir

Medical Device News – November 2023 Regulatory Update

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 09 Nov 2023 00:00:00 +0000

EU:

UDI for contact lenses Master-UDI-DI: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202302197
EUDAMED Roadmap It is a DRAFT: https://health.ec.europa.eu/system/files/2023-10/md_eudamed_roadmap_en.pdf

MDCG 2023-4 guidance – Validate the combination with hardware https://health.ec.europa.eu/system/files/2023-10/md_mdcg_2023-4_software_en.pdf
Fees and charges payable to EMA: Expert Panel will cost you money : https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CONSIL:ST_14057_2023_INIT
Notified Bodies : Finland and Turkey
- Sertio Oy (Finland) IVDR: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications/1001622
- Notice Belgelendirme (1st Turkish Notified Body) MDR: https://api.tech.ec.europa.eu/nando-prod/files?repo=nando&id=82870fd17389fc19149f103e8121acdc82fea1af&group=NOTIFICATION
- Team-NB call for action to Manufacturers to apply: https://www.team-nb.org/wp-content/uploads/2023/10/Team-NB-PressRelease-Capacity-NotifiedBodies-during-transition-IVDR-MDR-October2023.pdf

Training for you

Increase your knowledge in QA RA :

Vigilance Reporting in EU: https://school.easymedicaldevice.com/course/vigilance-reporting-eu-legislation/
Audit readiness: https://school.easymedicaldevice.com/course/etraining-audit-readiness/
Green Belt training: December 11th until December 15th: LINK

Spain:

Implementation of the HTA : EU Health Technology Assessment Regulations: https://www.aemps.gob.es/la-aemps/de-la-teoria-a-la-practica-implementacion-del-reglamento-de-evaluacion-de-tecnologias-sanitarias-de-la-ue/
Regulation 2021/2282 on health technology assessment: https://health.ec.europa.eu/publications/regulation-eu-20212282-health-technology-assessment_en

Switzerland:

Products without an intended medical purpose : Same as EU MDR: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/mu600_00_007d_mb_produkte_ohne_medizinische_zweckbestimmung.pdf.download.pdf/MU600_00_007e_MB_Devices_without_an_intended_medical_purpose.pdf
Obligation Economic Operators –: Update due to extension https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/mu600_00_016d_mb_pflichten_wirtschaftsakteure_ch.pdf.download.pdf/MU600_00_016e_MB_Obligations_Economic_Operators_CH.pdf
General procedure for foreign governmental inspections – Inform Swissmedic before governments audit a manufacturer https://www.swissmedic.ch/dam/swissmedic/en/dokumente/bewilligungen/i-308/i-308_aa_02-A01e_general_procedure_for_foreign_governmental_inspections_switzerland.pdf.download.pdf/I-308.AA.02-A01e_Merkblatt_General_procedure_foreign_govern_insp_CH_related_therapeutic_prod.pdf

MedTech Conf

Map of conferences available

Conferences Map: https://medtechconf.com/
Medica Dusseldorf November 13 -15 : https://medtechconf.com/event/medica-2023/
TEAM-PRRC Strasbourg November 16 – 17: https://medtechconf.com/event/team-prrc-annual-summit-2023/

Turkey:

Product not considered as a Medical Device – List of products available: https://titck.gov.tr/duyuru/tibbi-cihaz-yonetmelikleri-kapsaminda-degerlendirilmeyen-urunler-30102023120556

eQMS SmartEye:

SmartEye is your eQMS – Ask for your DEMO : https://smart-eye.io/

USA:

eStar is your new 510k : Since October 1st, 2023: https://www.fda.gov/media/152429/download

Australia:

Webinar on UDI for Australia – November 21st, 2023 11.30 AEDT: https://www.tga.gov.au/resources/event/webinars/unique-device-identification-udi-webinar-19-australian-udi-project-update-and-discussing-considerations-and-real-world-benefits-adopting-udi-healthcare

Podcast Nostalgia : You remember

What are some pitfalls to avoid during Software Design? Weronika Michaluk: https://podcast.easymedicaldevice.com/253-2/
Affrisummit 2023 Part 1 Morad Ajan, Rana Chalhoub, Dr. Mona Al Moussali: https://podcast.easymedicaldevice.com/254-2/
Afrisummit 2023 Part 2 Nora El-Hariri and Mohamed Mahdy Ghonim: https://podcast.easymedicaldevice.com/255-2/
Validate your iPhone, Samsung Galaxy, Huawei for your Software Erik Vollebregt: https://podcast.easymedicaldevice.com/256-2/

The post Medical Device News – November 2023 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

Validate your Iphone, Samsung Galaxy, Huawei… for your Software

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 31 Oct 2023 00:00:00 +0000

This MDCG came like evidence but comments on it where more confusion. What exactly was the objective of the MDCG 2023-4. We will try to explain to you on this podcast with Erik Vollebregt from Axon Lawyers.

Who is Erik Vollebregt?

Erik specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software, and protection of personal data. He is an expert in life sciences regulation at the EU and Dutch level, with a focus on contracts, regulatory litigation against competent authorities, and M&A. Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms. He actively contributes to law and policy development at the national and EU levels via membership of specialized committees at branch associations and the European Commission. Erik also works as an arbitrator in medical devices-related disputes and is regularly retained as an expert witness in foreign litigation. Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish. Chambers Europe 2017: Erik is known for his specialism in regulatory work, which covers medical technology, devices, and products as well as for biotechnology. Clients confirm his strong capabilities, with one saying “he stands out to me. Whenever I work with lawyers he has been the best, with a solid scientific background. He has the perfect combination of skills and experience.”

Who is Monir El Azzouzi?

Social Media to follow

■ Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
■ Twitter: https://twitter.com/elazzouzim
■ Pinterest: https://www.pinterest.com/easymedicaldevice
■ Instagram: https://www.instagram.com/easymedicaldevice

The post Validate your Iphone, Samsung Galaxy, Huawei… for your Software appeared first on Medical Device made Easy Podcast. hamza benafqir

Afrisummit 2023 Interviews Part 2 – Egypt Situation

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 24 Oct 2023 00:00:00 +0000

The Afrisummit 2023 in Egypt is over, and I came back with some interviews of some key stakeholders. This is the part 2 where we will focus on the Egypt situation.

Check Part 1 for the first interviews with (https://podcast.easymedicaldevice.com/254-2/):

– Morad Ajan – Head of Medical Device Unit at Direction du Médicament et de la Pharmacie (DMP) – Morocco
– Rana Chalhoub – Regulatory Affairs Director at Mecomed.

– Dr. Mona Al Moussali – Co-founder PRA Consultancy and organizer of the Afrisummit.

In this part 2 we have:

– Noha El-Hariri – Head Regulatory Affairs Medical Device
– Mohamed Mahdy Ghonim – IVD Manufacturer in Egypt

Who is Monir El Azzouzi?

Link

■ Noha El-Hariri LinkedIn Page: https://www.linkedin.com/in/noha-el-hariri-a46a1285/
■ EDA Webpage: https://www.edaegypt.gov.eg/
■ Mohamed Mahdy Ghonim LinkedIn Page: https://www.linkedin.com/in/mohamed-ghonim-1444102b/
■ Mohamed Mahdy Ghonim Qualitech International: https://www.qt-int.nl/
■ Thequa medical: https://www.thequa-med.com/
■ Afrisummit: https://www.linkedin.com/company/pharmaregafrisummit/

Social Media to follow

■ Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
■ Twitter: https://twitter.com/elazzouzim
■ Pinterest: https://www.pinterest.com/easymedicaldevice
■ Instagram: https://www.instagram.com/easymedicaldevice

The post Afrisummit 2023 Interviews Part 2 – Egypt Situation appeared first on Medical Device made Easy Podcast. hamza benafqir

Afrisummit 2023 Interviews Part 1

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 17 Oct 2023 00:00:00 +0000

The Afrisummit 2023 in Egypt is over, and I came back with some interviews of some key stakeholders.

First, I have the interview with Morad Ajan – Head of Medical Device Unit at Direction du Médicament et de la Pharmacie (DMP) – Morocco. We reviewed the Quality and Regulatory situation of Morocco and learned a lot of good information about progress that the authorities are ongoing to be modernized.

Second, we have the interview with Rana Chalhoub – Regulatory Affairs Director at Mecomed. We reviewed the situation in Middle East and Africa and why a summit like Afrisummit is important.

Third, the interview with Dr. Mona Al Moussali – Co-founder PRA Consultancy and organizer of the Afrisummit. We reviewed how the summit went and what are some feedback out of it.

Who is Monir El Azzouzi?

Link

Morad Ajan LinkedIn Page: https://www.linkedin.com/in/ajanm/
DMP website: https://dmp.sante.gov.ma/
Rana Chalhoub LinkedIn Page: https://www.linkedin.com/in/rana-chalhoub-8a391214/
Mecomed website: https://www.mecomed.com/
Dr Mona Al Moussali LinkedIn Page: https://www.linkedin.com/in/mona-almoussli/
PRA Consultancy Website: https://pra-me.com/
Afrisummit: https://www.linkedin.com/company/pharmaregafrisummit/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Afrisummit 2023 Interviews Part 1 appeared first on Medical Device made Easy Podcast. hamza benafqir

What are some pitfalls to avoid during Software Design?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 10 Oct 2023 00:00:00 +0000

More and more companies are starting to develop Software as Medical Devices (SAMD) and in this podcast episode, I have invited Weronika Michaluk to talk to us about some pitfalls that you need to avoid.

Weronika will talk about:

– Risk Management
– Usability
– Documentation
– Expertise
– Interoperability and scalability
– Cybersecurity.

So don’t miss that and don’t hesitate to contact Easy Medical Device if you have some questions.

Who is Weronika Michaluk?

Weronika Michaluk is an experienced professional with a diverse background in the fields of biomedical engineering, international business, and public health. She is a Biomedical Engineer by training, holds a Master’s degree in International Business from the University of Miami, an MBA from the Warsaw School of Management, and a Doctorate in Public Health (DPH) with a specific focus on the business strategy of Agile Development of Software as a Medical Device (SaMD).  Weronika’s career began as a Biomedical Engineer, where she contributed to the development of various biomedical devices, including a wireless ECG system, then she worked in South Korea in the Neuroscience Department and after that she focused on digital health solutions and consulting in the medical device space.

Currently, Weronika serves as the Digital Health Principal and SaMD Lead at HTD. In this role, she leads the Software as a Medical Device department, utilizing her expertise in biomedical engineering and business acumen. Her primary objective is to ensure that all products are meticulously designed and developed, adhering to the highest quality standards. Weronika’s dedication to customer satisfaction and patient safety is instrumental in driving the success of the organization and its customers. 

In her free time Weronika enjoys learning new languages (speaks 5 currently), travelling the world, playing sports, hiking ( she recently hiked Kilimanjaro, plans to hike to Mount Everest base camp next year) and discovering the unknown.

Who is Monir El Azzouzi?

Link

Weronika Michaluk LinkedIn Page: https://www.linkedin.com/in/weronika-michaluk-mba-43811698/
HTD Health website: https://htdhealth.com/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post What are some pitfalls to avoid during Software Design? appeared first on Medical Device made Easy Podcast. hamza benafqir

October 2023 Regulatory Update

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Wed, 04 Oct 2023 00:00:00 +0000

EU

Manual on Borderline and classification for Medical Devices Update – New entries to the file: https://health.ec.europa.eu/system/files/2023-09/md_borderline_manual_en.pdf
Q&A on Annex XVI Products – Check transition timeline: https://health.ec.europa.eu/system/files/2023-09/md_new-reg_annex-xvi_q-n-a_transition-prov.pdf
Italy: Custom-made medical device registration – Specific website available: https://www.salute.gov.it/portale/news/p3_2_1_1_1.jsp?lingua=italiano&menu=notizie&p=dalministero&id=6352
Ireland: Custom-made device Webinar October 19th, 2023 – Webinar to join: https://www.hpra.ie/homepage/medical-devices/news-events/item?t=/custom-made-device-(cmd)-regulation-webinar&id=5ad21426-9782-6eee-9b55-ff00008c97d0
Team-NB – Training on MDR Technical Documentation for Manufacturers – Date of the event November 7th, 2023: https://www.team-nb.org/new-team-nb-initiative-mdr-technical-documentation-training-for-manufacturers/
- Technical Documentation template Premium Pack: https://school.easymedicaldevice.com/product/eu-mdr-technical-file-premium-pack/
FIMEA designate first Notified Body under the IVD regulation in Finland – EUROFINS Electric & Electronics Finland Oy: http s://www.fimea.fi/web/en/-/fimea-designates-the-first-notified-body-under-the-ivd-regulation-in-finland

UK

The innovation Devices Access Pathway (IDAP) – Pilot Phase to join – Answer before October 29th, 2023: https://www.gov.uk/government/pu blications/the-innovative-devices-access-pathway-idap/the-innovative-devices-access-pathway-idap-pilot-phase

CH

Swissdamed Survey Report – The EUDAMED for Switzerland to start in 2024: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/infos/survey-results-report.pdf.download.pdf/20230919_swissdamed_survey%20results%20report.pdf

Conferences

Which conferences to focus on? -I will be going to them so join me.

MEDXD: Digitalisation of Medtech: https://medtechx.digital/
Afrisummit in Egypt: h ttp s://www.pharmaregafrisummit.com/
Medica: https://www.medica-tradefair.com/
Team-PRRC: https://www.team-prrc.eu/

Training

Trainings for you – Self-paced

Vigilance Reporting: https://school.easymedicaldevice.com/course/vigilance-reporting-eu-legislation/
Audit Readiness: https://school.easymedicaldevice.com/course/etraining-audit-readiness/

US

US FDA – De Novo Request – Electronic Submission template: https://www.fda.gov/media/172450/download
Webinar US FDA – Cybersecurity in Medical Devices: – November 2nd 2023: https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-final-guidance-cybersecurity-medical-devices-quality-system-considerations-and-content
Webinar US FDA – Breakthrough devices program update – November 14th, 2023: https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-breakthrough-devices-program-updated-final-guidance-11142023
Digital Health FAQ – Is your medical device an SaMD?: https://www.fda.gov/medical-devices/digital-health-center-excellence/digital-health-frequently-asked-questions-faqs
ISO 10993-1:2018 versus FDA – FDA is adding its touch: https://www.fda.gov/media/142959/download
Best practice for selecting a Predicate device for your 510K – Method provided. https://www.fda.gov/media/171838/download

Saudi Arabia

SFDA Significant changes guidance – Template inside: https://www.sfda.gov.sa/sites/default/files/2023-09/MDS-G12a.pdf

Malaysia

Malaysia: Workshop preparation of documents for Submission – October 23rd, 24th and 30th: https://www.mda.gov.my/announcement/1285-first-announcement-hands-on-workshop-efficient-way-to-prepare-for-mda-documentation-submissions.html

Turkey

Mutual Recognition of Authorized rep and NB in Turkey – Good clarification: https://titck.gov.tr/duyuru/tcokka-mutual-recognition-of-authorized-representatives-and-notified-bodies-in-the-field-of-medical-devices-between-the-eu-and-turkiye-19092023160242

Japan

Japan: Essential Principles – In 2023 inclusion of the Cybersecurity risks: https://www.std.pmda.go.jp/stdDB/Data_en/InfData/Infetc/MHLW_Notification_122_of_2005.pdf

India

India: List of registered medical device testing laboratory – under Indian mdr 2017: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTA1MTE=

Podcast

Podcast Nostalgia – Do you remember?

Episode 249: Team-PRRC interviews part 1 : https://podcast.easymedicaldevice.com/249-2/
and 250: part 2: https://podcast.easymedicaldevice.com/250-2/
Episode 251: EUDAMED Updates: https://podcast.easymedicaldevice.com/251-2/

QMS

How Easy Medical Device can help you –easymedicaldevice.com

We can also help you implement our eQMS – Smarteye: https://smart-eye.io

The post October 2023 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

What is the EUDAMED Updates?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 26 Sep 2023 00:00:00 +0000

EUDAMED is the European Database for Medical Devices. In this episode, Richard Houlihan will be my guest and will explain to us the situation regarding EUDAMED. For the moment this database is not finished, so should you use it? We will also review the timeline and help you understand what you should do now. Don’t miss that episode as EU MDR 2017/745 and IVDR 2017/746 ask you to register your company, your products in this database.

Who is Richard Houlihan?

Richard Houlihan is an international speaker and guest university lecturer on EUDAMED. His time running the European Commission IT teams developing EUDAMED has given him unrivalled insights into how EUDAMED affects the MedTech industry. This EUDAMED experience and his 28 years in IT give him a real advantage when helping companies prepare for EUDAMED, FDA GUDID, and other regulatory submissions.   His company EirMed with the website eudamed.com provides EUDAMED regulatory submission software solutions to help Manufacturers large and small including full project management, training, an EUDAMED mobile search app, and support to help Manufacturers, Importers, European authorised reps, and Distributors meet their EUDAMED obligations. To date, Richard and his team have trained over a thousand people on EUDAMED and helped hundreds of companies with EUDAMED consultancy and their regulatory data submissions to EUDAMED.

Who is Monir El Azzouzi?

Link:

Richard Houlihan LinkedIn: https://www.linkedin.com/in/richard-houlihan/
EUDAMED.Com website: https://eudamed.com/
EUDAMED database link: https://ec.europa.eu/tools/eudamed/#/screen/home
EUDAMED registration page: https://webgate.ec.europa.eu/eudamed/landing-page#/
EUDAMED and Germany: https://www.bfarm.de/EN/Medical-devices/Overview/Europe-and-EUDAMED/_node.html
EMDN Code Website: https://webgate.ec.europa.eu/dyna2/emdn/ Meeting Minute EUDAMED timeline: https://ec.europa.eu/transparency/expert-groups-register/screen/meetings/consult?lang=en&meetingId=48063&fromExpertGroups=3565
Playground: https://webgate.training.ec.europa.eu/eudamed-play

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post What is the EUDAMED Updates? appeared first on Medical Device made Easy Podcast. hamza benafqir

Interviews on Being The PRRC (Part 2)

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 19 Sep 2023 00:00:00 +0000

In this second part of this podcast series on Team-Prrc interviews. we have 3 additional guests. Don’t miss the first one where we also got great interviews. In this episode, we will interview

Bassil Akra about the Team-PRRC event and why you should come. This will happen again on November 16th and 17th.
Elena Kyria on the way a recruiter should work to find a suitable PRRC for your company
Elem Ayne, the Team-PRRC president will explain to us more about the event and how this first session went.

So don’t miss the next opportunity to meet everyone at the Team-PRRC event in Strasbourg – France on November 16th and 17th. You’ll be able to create a great network.

Links from the Video

Bassil Akra Linkedin: https://www.linkedin.com/in/bassil-akra-akrateam/
Elena Kyria Linkedin: https://www.linkedin.com/in/elenakyria/
Elem Ayne Linkedin: https://www.linkedin.com/in/elemayne/
Team-PRRC Event: https://www.team-prrc.eu/page/1111392-presentation
Medical Device: All about the role of PRRC: https://www.youtube.com/watch?v=RCBYA1wLQLU

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Interviews on Being The PRRC (Part 2) appeared first on Medical Device made Easy Podcast. hamza benafqir

Interviews on Being The PRRC

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Wed, 13 Sep 2023 00:00:00 +0000

Within this video you will see 4 interviews on the PRRC role. First one with Piero Costa where we will talk about the role of a PRRC within the different economic operators The second one with Erik Vollebregt where we will review the role of a PRRC and liability The third one with Ronald Boumans where we will explain how to behave to be a PRRC And the last one with Christopher Kipp from BVMed on the PRRC role in Germany with the already existing safety officer. Don’t miss the next Team-PRRC event November 16-17 2023 in Strasbourg.

Who is Monir El Azzouzi?

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Interviews on Being The PRRC appeared first on Medical Device made Easy Podcast. hamza benafqir

MEDICAL DEVICE NEWS – SEPTEMBER 2023 Regulatory Update

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Wed, 06 Sep 2023 07:51:27 +0000

EU

MDR and IVDR communication Survey: https://ec.europa.eu/eusurvey/runner/MDR_and_IVDR_Communication_Survey
EU MDR transition
- Q&A implementation of MDR extension 2023/607: https://health.ec.europa.eu/system/files/2023-07/mdr_proposal_extension-q-n-a.pdf
- Flowchart to a decision on the extended MDR transitional period: https://health.ec.europa.eu/document/download/2d29bd99-8523-4c13-bbf5-cc36fcecea93_en?filename=md_devices-art120_flowchart.pdf
- Team-NB: New MDR Transition Timeline and Notified Body Capacity: https://www.team-nb.org/wp-content/uploads/2023/08/Team-NB-PositionPaper-MDRTransitionTimelines-NotifiedBodyCapacity-V1.pdf
- Blog Post – Erik Vollebregt . Can we fix/improve the MDR and the IVDR? https://medicaldeviceslegal.com/2023/08/29/can-we-fix-improve-the-mdr-and-the-ivdr/
Team-NB: Transfer agreement:https://www.team-nb.org/wp-content/uploads/2023/08/Team-NB-PositionPaper-TransferAgreement-V1-20230811.pdf
Notified Bodies situation :https://health.ec.europa.eu/document/download/3d407427-fad0-498a-b1ef-2db28c9f4423_en?filename=notifiedbodies_overview_en.pdf
EMA consultation: https://www.ema.europa.eu/en/documents/other/questions-answers-consultation-procedure-european-medicines-agency-notified-bodies-ancillary_en.pdf

Training offered:

Vigilance Reporting: https://school.easymedicaldevice.com/course/vigilance-reporting-eu-legislation/
Audit readiness: https://school.easymedicaldevice.com/course/etraining-audit-readiness/
Green Belt: https://school.easymedicaldevice.com/course/gb26/

UK:

CE Marking recognition: https://www.gov.uk/government/news/ce-marking-recognition-for-medical-devices-and-in-vitro-diagnostics?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=70128116-5d7a-4e60-89d6-99e578f8a33b&utm_content=immediately
3 new UK Approved bodies :https://www.gov.uk/government/news/three-new-uk-approved-bodies-to-certify-medical-devices-announced-by-the-mhra
- Approved Body list: https://www.gov.uk/government/publications/medical-devices-uk-approved-bodies

TGA:

Webinar :
- The new Medical devices Vigilance Program- Information for medical device Sponsors in Australia: https://www.tga.gov.au/resources/event/webinars/new-medical-devices-vigilance-program-information-session-medical-device-sponsors-australia
- UDI: https://www.tga.gov.au/resources/event/webinars/unique-device-identification-webinar-18-project-checkpoint-what-we-know-and-what-you-can-do-get-involved

Canada:

Pre-market guidance for Machine learning-enabled : https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/pre-market-guidance-machine-learning-enabled-medical-devices.html

USA:

Off-the-Shelf Software :https://www.fda.gov/media/71794/download

Saudi Arabia:

ISO 13485 for manufacturers & supplies facilities : https://www.sfda.gov.sa/sites/default/files/2023-08/MD-Quality13485.pdf

eQMS:

SmartEye : https://smart-eye.io

Conferences

MEDXD – Berlin Germany September 26 and 27- https://medtechx.digital/
Afrisummit – Cairo Egypt https://www.pharmaregafrisummit.com/meddev/
MEDICA – Dusseldorf Germany https://www.medica-tradefair.com/
Team-PRRC – Strasbourg France https://www.team-prrc.eu/page/1111392-presentation

Podcast to listen

Medical Misfits episode: How to join a Tech Startup as a Medical Student: https://www.medicalmisfits.com/zoe-lee/
The Medtech Podcast by Karandeep Badwal: https://open.spotify.com/show/32CvtseLj3KknqYDFdO7P3
The Med-Tech Talent Lab with Mitch Robbins: https://open.spotify.com/show/4b6r5OPbgsS6DqhCZuAFG2
Life Science 360 with Harsh Thakkar: https://www.lifesciencespod.com/2079900
State of Medtech with Omar Khateeb: https://open.spotify.com/show/5NVrQLfLk0EXDeKDdX7BB6

Podcast Nostalgia

Who should be on your Risk Management Dream Team with Naveen Agarwal: https://podcast.easymedicaldevice.com/243-2/
Hire your QA RA employee with no Budget with Mitch Robbins: https://podcast.easymedicaldevice.com/244-2/
Why you should automate your Software Validation with Christophe Girardey and Virginie Rochat? https://podcast.easymedicaldevice.com/245-2/
What are the Acceptance Criteria for your Clinical Evaluation with Cesare Magri. https://podcast.easymedicaldevice.com/246-2/
How to perform your Cleaning Validation in practice? With Enrico Allegra: https://podcast.easymedicaldevice.com/247-2/

The post MEDICAL DEVICE NEWS – SEPTEMBER 2023 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

How to perform your Cleaning Validation in practice?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 29 Aug 2023 00:00:00 +0000

Medical Devices that are reusable should be cleaned. But the user is not a professional of your product so he needs to receive some instruction on how to clean it. In this episode of the podcast we will explain to you what is cleaning validation and also talk about microbiology, electrical device cleaning, Notified Body issues…

So let’s listen to Enrico Allegra from TestLabs who will share with us his experience.

Who is Enrico Allegra?

Enrico has over 10 years of experience in regulatory microbiology combining environmental safety with clinical settings as a study director. He graduated with a Bachelor of Science degree in Immunology with Medical Microbiology followed by a master’s degree in Clinical Microbiology from Queen Mary University of London in 2013. During his previous role, he worked extensively in method transfer and development. His work spanned from environmental microbiology to clinical settings.

He worked on clinical trials to assess the validity of vaccination against Group B Streptococci in pregnant women.

He was strongly involved in the assessment of the safety of agrochemical products such as biocides as well as being the lead scientist for the assessment of antimicrobial susceptibility testing of pre and probiotic products. During his time working in safety assessment, he collaborated on a CRACK-IT sponsored research under the NC3Rs as the lead scientist.

The research focused on evaluating the discrimination of toxic and non-toxic chemicals using wax moth larvae Galleria mellonella as model to help reduce, replace, and refine the use of animal models.

The research was published for Chemosphere (Elsevier) in May 2018. During the height of the pandemic, he worked on the development of antiviral assays against Coronavirus as well as being part of clinical trial of bacteriophage technology to help fighting secondary infection of cystic fibrosis patients.

He is a certified biosafety officer and operates as the Head of Laboratory at Test Labs, a Medical Device testing laboratory. Enrico massively helped developing the facility from an empty canvas to a fully operational ISO 17025:2017 accredited laboratory, in less than 11 months. Leading the microbiology, chemistry and material sciences teams in performing Medical Device testing, he provides expert knowledge combining the experience in method validation and new method development to help customer with reliable and fully validated reports.

Who is Monir El Azzouzi?

Links from the Video

■Enrico Allegra LinkedIn: https://www.linkedin.com/in/enrico-allegra-b97751164
■TestLabs LinkedIn Page: https://www.linkedin.com/company/testlabsuk/
■TestLabs webpage: https://testlabsuk.com/

Social Media to follow

■ Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
■ Twitter: https://twitter.com/elazzouzim
■ Pinterest: https://www.pinterest.com/easymedicaldevice
■ Instagram: https://www.instagram.com/easymedicaldevice

The post How to perform your Cleaning Validation in practice? appeared first on Medical Device made Easy Podcast. hamza benafqir

What are the Acceptance Criteria for your Clinical Evaluation?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 22 Aug 2023 01:07:20 +0000

We all are afraid of one thing. It is to see our Clinical Evaluation rejected by a Notified Body. Why? Because apparently EU MDR is creating a more restrictive environment for accepting what was acceptable before. So let’s review in this episode the acceptance criteria for your Clinical Evaluation and what kind of surprises you would maybe discover all along the way. For that I have invited Cesare Magri from 4BetterDevices to help us understand this pathway and take the right road at the crosses.

Who is Cesare Magri?

Who is Monir El Azzouzi?

Link:

-Cesare Magri Linkedin : https://www.linkedin.com/in/cesare-magri/ 4BetterDevices
-LinkedIn Page: https://www.linkedin.com/company/4betterdevices/
-Website 4BetterDevices: https://4betterdevices.com/

Social Media to follow

-Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
-Twitter: https://twitter.com/elazzouzim
-Pinterest: https://www.pinterest.com/easymedicaldevice
-Instagram: https://www.instagram.com/easymedicaldevice

The post What are the Acceptance Criteria for your Clinical Evaluation? appeared first on Medical Device made Easy Podcast. hamza benafqir

Why you should automate your Software validation?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 15 Aug 2023 00:00:00 +0000

Software validation is key. This is mentioned on different standards, and this is required by the auditors to prove that your software is safe. This is valid for Software as a Medical Device SaMD but also to software used as a quality tool. ISO 13485 is asking you to validate software’s that are used to track quality data.

In this episode, Christophe Girardey and Viriginie Rochat from Wega will explain to us the next level of the software validation which is the automation. Imagine that you can automate your validation and you don’t need to test everything manually. That would save you a lot of time. But what are the benefits or pitfalls of it?

Don’t miss this episode if you are in software development or if you use Software to manage quality data.

Who is Christophe Girardey?

Christophe Girardey is Managing Director at Wega, a life science consulting company specializing in digitalization. Christophe is responsible for the Quality Assurance Team which supports Pharmaceutical and Medical Device companies when it comes to compliance of Software. Wega supports you through the software lifecycle with its expertise in the regulatory field, allowing you to concentrate on your expertise in medical software development. Wega can help you to optimize your Software Development processes to reach compliance/quality by design. This includes performing gap analysis, advising on how to implement agile methodologies in a compliant way, configuring and validating the different Software tools to reach an optimal and qualitative Software Development.

Christophe has 15 years of experience within the regulated industry and started his career as Software Developer prior moving to Quality Management activities and can hence best make the bridge between the SW Development and Quality Assurance Team by fostering innovation combined with compliance.

Who is Virginie Rochat?

Virginie is leading the Test Automation team at wega, a life science consulting company specialized in digitalization. The Test Automation team is composed of people with a broad range of backgrounds – from software and testing engineers to QA and Validation specialists – in order to support Pharmaceutical and Medical Device companies when it comes to automate end-to-end testing. With its expertise in user interface test automation tools, wega can support you through the selection of the proper tool based on your needs and infrastructure, validate the tool and then help your teams into the development of automated test cases and provide the necessary experience to support your team to reach compliance in a more efficient way.

Virginie has more than 10 years of experience within pharma laboratories. She has always been keen to automate repetitive tasks and prone to adopt new technologies to improve the efficiency of the business processes, leading her to develop more and more knowledge on informatic and technologies, to bridge the gap between Science and IT.

Who is Monir El Azzouzi?

Link:

Article on Test Automation: https://www.wega-it.com/en/automatisierung-von-softwaretests-fuer-nutzeranforderungen
Christophe Girardey Linkedin : https://www.linkedin.com/in/christophe-girardey-77ab6027/
Virginie Rochat Linkedin: https://www.linkedin.com/in/virginie-rochat86/
wega Website : https://www.wega-it.com/
Medical Device: https://www.wega-it.com/en/computer-systems-validation-quality-assurance#medical-device-compliance

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Why you should automate your Software validation? appeared first on Medical Device made Easy Podcast. hamza benafqir

Hire your QA RA person with no Budget

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 08 Aug 2023 08:02:40 +0000

Hiring a new candidate for your team is always a challenge. But how to do that when there is no Budget allocated to it. This is what we will show you in the podcast episode.

Mitch Robbins is a professional recruiter that has its own agency “The Anthony Michael Group”. He is able to help you on your research as he is specialised in QA RA recruitment. But he also knows your pain when your company cannot hire a recruiter for this mission. So, we will review what he proposes to you to be successful regarding this challenge.

Who is Mitch Robbins?

Mitch Robbins is the Founder and Managing Director of The Anthony Michael Group in a suburb of Denver, CO. Mitch and his team at AMG helps organizations (Med-Device, Diagnostics, and Digital Health) to hire the top 15% of Elite Technical Talent in areas like Regulatory Affairs, Quality, Engineering, R&D, Manufacturing and Operations. Mitch, himself, is consistently ranked across the world within the top 1% of Headhunters and has been the choice of the experts to deliver training to both rookies and seasoned recruiters across multiple disciplines on numerous occasions.

Who is Monir El Azzouzi?

Link:

Mitch Robbins Linkedin : https://www.linkedin.com/in/mitchrobbins
Linkedin Post: https://www.linkedin.com/posts/mitchrobbins_regulatoryaffairs-hiring-theanthonymichaelgroup-activity-7076976156570243073-kEsY/
Podcast Med-Tech Talent Lab: https://spoti.fi/3LqqubL
The Anthony Michael Group website: https://www.theanthonymichaelgroup.com

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Hire your QA RA person with no Budget appeared first on Medical Device made Easy Podcast. hamza benafqir

Who should be on your Risk Management Dream Team?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 01 Aug 2023 00:00:00 +0000

https://youtu.be/QiYehhfxbwg

When you look at ISO 13485 or EU MDR or US FDA, they all want to see that you are reducing the risk for your products. But to do that you have to brainstorm and identify those risks. Usually, we follow ISO 14971 for that. But not all of your team is aware of this, and we are now short on time. So, what to do? Draft it by yourself or work with some colleagues. Naveen Agarwal will be sharing with us the best way to collaborate to create a successful Risk Management process. So, let’s listen to that.

Who is Naveen Agarwal?

Who is Monir El Azzouzi?

Link:

Naveen Agarwal Linkedin : https://www.linkedin.com/in/naveenagarwal/
Linkedin Post: https://naveenagarwalphd.substack.com/p/collaboration-is-the-secret-sauce-for-riskmgmt

Achieve Website: https://www.achievexl.com
Let Us Talk Risk Newsletter: https://naveenagarwalphd.substack.com/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/
Subscribe to our LinkedIn Newsletter: https://www.linkedin.com/build-relation/newsletter-follow?entityUrn=7051455462466023424

The post Who should be on your Risk Management Dream Team? appeared first on Medical Device made Easy Podcast. hamza benafqir

Artificial Intelligence in the Medical Device Industry

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 25 Jul 2023 00:00:00 +0000

Artificial Intelligence is the actual hot topic that everyone is talking about. A lot of countries are starting to regulate this technology. But what are we talking about. This episode will help you understand AI and also understand what the risks to it are. This is really an interesting topic, but a lot of people are really afraid when we talk about AI. We will try to give you some tips to clarify the situation.

For that I have invited Christophe Girardey from Wega to answer my questions as he is helping companies who use Artificial Intelligence for their software.

Who is Christophe Girardey?

Who is Monir El Azzouzi?

Link:

Christophe Girardey Linkedin : https://www.linkedin.com/in/christophe-girardey-77ab6027/
Wega Website : https://www.wega-it.com/
Medical Device Compliance: https://www.wega-it.com/computer-systems-validation-quality-assurance#medical-device-compliance
Data Sciences: https://www.wega-it.com/clinical-development-it#data-science
Wega Breakfast: Artificial Intelligence in GxP environments: https://www.youtube.com/watch?v=dCDwEkXd9jU&t=11s

Nature Article (co-authored):
https://www.nature.com/articles/s41582-020-00448-7

FDA list of Software with AI: https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices?

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/
Subscribe to our LinkedIn Newsletter: https://www.linkedin.com/build-relation/newsletter-follow?entityUrn=7051455462466023424

The post Artificial Intelligence in the Medical Device Industry appeared first on Medical Device made Easy Podcast. hamza benafqir

Validation of Quality Software in Medical Devices

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 18 Jul 2023 00:00:00 +0000

https://youtu.be/wQvuFyROLv8

Have you ever been to an audit and the auditor is asking you to show them the validation of your Quality Management System software? The first reflex is to say “But I buy it like that so I don’t validate that” and the auditor to say “Ok, then there is a non-conformity to ISO 13485”. I know painful. So let’s review today the way to validate you Quality tools and why this seem so important. For that I have invited Christophe Girardey from Wega to answer my questions as he is helping companies to validate their software.

Who is Christophe Girardey?

Christophe Girardey is Managing Director at wega, a life science consulting company specialized in digitalization. Christophe is responsible for the Quality Assurance Team which supports Pharmaceutical and Medical Device companies when it comes to compliance of Software. wega supports you through the software lifecycle with its expertise in the regulatory field, allowing you to concentrate on your expertise in medical software development. wega can help you to optimize your Software Development processes to reach compliance/quality by design. This includes performing gap analysis, advising on how to implement agile methodologies in a compliant way, configuring and validating the different Software tools to reach an optimal and qualitative Software Development. Christophe has 15 years of experience within the regulated industry and started his career as Software Developer prior moving to Quality Management activities and can hence best make the bridge between the SW Development and Quality Assurance Team by fostering innovation combined with compliance.

Who is Monir El Azzouzi?

Links from the Video

Christophe Girardey Linkedin : https://www.linkedin.com/in/christophe-girardey-77ab6027/ Wega Website : https://www.wega-it.com/computer-systems-validation-quality-assurance#medical-device-compliance https://www.wega-it.com/computer-systems-validation-quality-assurance

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Validation of Quality Software in Medical Devices appeared first on Medical Device made Easy Podcast. hamza benafqir

How to register Medical Devices in Saudi Arabia?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 11 Jul 2023 01:00:00 +0000

I am sure that at a certain point, your company will try to market your medical devices in Saudi Arabia. And now you are looking for the information that will help you to accelerate the registration of the products. In this episode, Ahmed Hendawy from Registitute will help us understand the best strategy to do that. He will explain to us also the similarities between SFDA and EU MDR. So if you are really motivated to register your product within SFDA then this is the right podcast episode for you.

Who is Ahmed Hendawy?

Ahmed is an esteemed leader in the field of healthcare consulting, renowned for his deep expertise in healthcare regulations, market access, and business strategy within the MENA region. As the founder and driving force behind Registitute, Ahmed has established the firm as a premier provider of specialized services in regulatory affairs and market access.
With a distinguished career, including a previous role as the Head of Regulatory Affairs for the MENA region, Ahmed has demonstrated exceptional skill in navigating complex regulations and spearheading successful market entry strategies. Under his visionary guidance, Registitute has garnered a reputation for excellence and innovation in the healthcare consulting landscape.
Registitute stands apart by delivering tailored solutions that address the unique challenges faced by healthcare organizations operating in the MENA region. Ahmed’s strategic vision, combined with the expertise of the Registitute team, continues to drive positive change and support healthcare organizations in adapting to the ever-evolving healthcare landscape in the MENA region.
In summary, Ahmed’s leadership and Registitute’s unwavering commitment to providing exceptional services position them as a trusted partner for healthcare organizations seeking regulatory expertise and market access support in the MENA region.

Who is Monir El Azzouzi?

Link:

Ahmed Hendawy Linkedin : https://www.linkedin.com/in/ahmed-hendawy-a0a81511a
Registitute LinkedIn: https://www.linkedin.com/company/registitute/
Registitute Website : www.registitute.com
AL TIRYAQ LinkedIn : https://www.linkedin.com/company/al-tiryaq/

SFDA website : www.sfda.gov.sa
SFDA Guidance for Medical Device registration: https://sfda.gov.sa/sites/default/files/2019-12/MDS-G5_1.pdf

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/
Subscribe to our LinkedIn Newsletter: https://www.linkedin.com/build-relation/newsletter-follow?entityUrn=7051455462466023424

The post How to register Medical Devices in Saudi Arabia? appeared first on Medical Device made Easy Podcast. hamza benafqir

Medical Device News – July 2023 Regulatory Update

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 04 Jul 2023 08:15:26 +0000

Sponsor Medboard https://www.medboard.com/

EU

Annex XVI transition https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32023R1194

Cybersecurity and privacy in AI https://www.enisa.europa.eu/publications/cybersecurity-and-privacy-in-ai-medical-imaging-diagnosis

ANSM wants barcode on Field Safety Notice https://ansm.sante.fr/actualites/lansm-demande-aux-fabricants-de-dispositifs-medicaux-qui-envoient-un-avis-de-securite-dy-apposer-le-code-barres-des-dispositifs-concernes

AEMPS clinical trials involving drugs and medical devices https://www.aemps.gob.es/informa/la-aemps-informa-sobre-el-procedimiento-a-seguir-en-los-ensayos-clinicos-que-impliquen-medicamentos-y-productos-sanitarios/

Switzerland

Medicinal products with a medical device component https://www.swissmedic.ch/swissmedic/en/home/news/mitteilungen/am-mit-mepkomponente-uebergangsbestimmungen.html

Implementation of the Future Regulations https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices-and-extension-of-standstill-period/implementation-of-the-future-regulations

eQMS

Do you need an eQMS? https://smart-eye.io
- So contact info@scube-technologies.com to get a demo

USA

Premarket notification for Software https://www.fda.gov/media/153781/download
- Webinar – Final Guidance: Content of Premarket Submissions for Device Software Functions https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-final-guidance-content-premarket-submissions-device-software-functions-07202023

Australia

TGA Use of market authorization evidence https://www.tga.gov.au/resources/resource/guidance/use-market-authorisation-evidence-comparable-overseas-regulators-assessment-bodies-medical-devices-including-ivds

Malaysia

Malaysia rules on EU MDR extension https://www.mda.gov.my/announcement/1224-announcement-mda-approach-on-expired-ec-certificate-for-new-registration-and-re-registration-of-medical-device.html

Saudi Arabia

Saudi Arabia Webinars
- Artificial Intelligence and Software Based on Medical Device https://www.sfda.gov.sa/en/workshop/88535
- Introducing the Rules for Classifying the Risk of Medical Devices https://www.sfda.gov.sa/en/workshop/88536

Authorized Representative

Europe. https://easymedicaldevice.com/eu-rep/
UK: https://easymedicaldevice.com/uk-responsible-person/
Switzerland: https://easymedicaldevice.com/swiss-authorised-representative/

Podcast Nostalgia:

The great Misunderstanding with Florian Tolkmitt: https://podcast.easymedicaldevice.com/236-2/

How to connect Software dev and QARA team with Christophe Girargey Wega: https://podcast.easymedicaldevice.com/237-2/
What should you know on the UKCA extension with Alex Denoon: https://podcast.easymedicaldevice.com/238-2/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/
Subscribe to our LinkedIn Newsletter: https://www.linkedin.com/build-relation/newsletter-follow?entityUrn=7051455462466023424

The post Medical Device News – July 2023 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

What should you know on UKCA extension

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 27 Jun 2023 00:01:00 +0000

Since Brexit happened, there are multiple waves of changes in the UK. First the UK Responsible Person (which is a hybrid of the EU AR and the EU Importer), then the UKCA requirements, then the new legislation consultation (which will largely harmonise UK law with the MDR and IVDR) and now the extension of the unilateral recognition of CE Marks to allow manufacturers more time to obtain a UKCA marks.

But what all this means for medical devices manufacturers that are already selling in the UK or that plan to sell to the UK. We will review that with Alex Denoon, partner at Bristows.

Don’t forget to check the links below for more details.

Who is Alex Denoon?

Alex advises about Life Sciences regulatory issues all day every day and has been doing so for 30 years.

He enjoys working with clients to devise and implement regulatory strategies throughout the product life cycle of pharmaceuticals, medical devices and IVDs. Alex has been involved in the development of a number of regulatory frameworks and guidelines. Legal 500 describes Alex as “a straight-talking, commercially astute technology specialist who is always willing to take a view” and who delivers “out-of-the-box solutions”.

Who is Monir El Azzouzi?

Link:

Alex Denoon Linkedin : https://www.linkedin.com/in/alexdenoon
Bristows law firm linkedin page: https://www.linkedin.com/company/bristows/
Bristows Website : https://www.bristows.com/
Bristows Blog post on UKCA: https://www.bristows.com/news/will-we-ever-see-a-ukca-mark-for-medical-devices/#:~:text=Currently%2C%20the%20UK’s%20medical%20device,conformity%20marking%2C%20the%20UKCA%20mark
UKCA future implementation: https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices-and-extension-of-standstill-period/implementation-of-the-future-regulations
Infographics timeline: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1164062/Infographic_-_Devices_transition_timeline.pdf
How to register a Medical Device in the UK: https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk
Your UK Responsible Person: https://easymedicaldevice.com/uk-responsible-person/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post What should you know on UKCA extension appeared first on Medical Device made Easy Podcast. hamza benafqir

How to connect Software dev and QA RA Team

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 20 Jun 2023 00:00:00 +0000

Software development is really increasing in the Medical Device world and it is maybe important now to discuss about potential gaps that exist between the Software Development team and the Quality and Regulatory Affairs team. Dev team think that they have too much documents to create and quality thinks that the document that the dev team is creating is not really answering the requirements. So how to solve that.

Christophe Girardey from Wega who is dealing with that will tell us why we have this situation and also provide some hints on how this can be resolved.

Who is Christophe Girardey?

Who is Monir El Azzouzi?

Link:

Christophe Girardey Linkedin : https://www.linkedin.com/in/christophe-girardey-77ab6027/
Wega Website : https://www.wega-it.com/
Medical Device: https://www.wega-it.com/computer-systems-validation-quality-assurance#medical-device-compliance
Agile : https://www.wega-it.com/computer-systems-validation-quality-assurance#agility-in-gxp

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post How to connect Software dev and QA RA Team appeared first on Medical Device made Easy Podcast. hamza benafqir

The great misunderstanding of EU MDR amendments

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 13 Jun 2023 00:00:00 +0000

Since March 2023 an extension for EU MDR and IVDR was voted by the EU Commission. This podcast episode will remind you the latest news and also answer some frequently asked questions from people. As you may see on the title there are some great misunderstandings, and the objective of today is to clear that out.

For that I have with me Florian Tolkmitt from Pro-Liance and we will try to give you the best content on EU MDR extension.

Who is Florian Tolkmitt?

Florian Tolkmitt is co-founder and CEO of PRO-LIANCE, a consultancy supporting medical device manufacturers with regulatory affairs, clinical affairs and quality management. PRO-LIANCE is based in Germany and serves customers. Florians favorite topics include clinical evaluation, post-market surveillance and risk management and he is also assistant professor at the University of Applied Sciences in Luebeck, Germany, where he teaches Clinical Evaluation to Master students. Apart from that he is the chair of the Regulatory Affairs Professionals Society Chapter in Germany and loves to network and bring the Regulatory Affairs and Quality Community closer together. Last but not least, Florian has a strong interest in Digitalization and is a founding member of the Medical Device Knowledge Unit initiative, that works on an open-source data model for Technical Documentation.

Who is Monir El Azzouzi?

Link:

EU MDR extension: https://health.ec.europa.eu/system/files/2023-03/mdr_proposal_extension-q-n-a_0.pdf

Team NB Notified Body confirmation letter: https://www.team-nb.org/wp-content/uploads/members/M2023/Team-NB-PositionPaper-NB-ConfirmationLetterEU2023-607-20230503.docx
Florian Tolkmitt Linkedin : https://www.linkedin.com/in/floriantolkmitt/
Pro-Liance company Site: https://pro-liance.com/
EU 2023/607: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32023R0607
Podcast episode EU extension with Erik Vollebregt: https://podcast.easymedicaldevice.com/211-2/
LinkedIn Company: https://www.linkedin.com/company/pro-liance/

Social Media to follow:

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post The great misunderstanding of EU MDR amendments appeared first on Medical Device made Easy Podcast. hamza benafqir

Medical Device News -June 2023 regulatory update

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 08 Jun 2023 00:00:00 +0000

Sponsor MedBoard: www.medboard.com

EUROPE

Notified Body overview: https://health.ec.europa.eu/system/files/2023-05/notifiedbodies_overview_en.pdf

EU MDR and IVDR consolidated versions
- EU MDR: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0745-20230320
- EU IVDR: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20230320

Confirmation letter: EU Commission: https://health.ec.europa.eu/latest-updates/template-nb-confirmation-letter-framework-regulation-eu-2023607-2023-05-24_en

MDCG 2020-3 Significant changes: https://health.ec.europa.eu/latest-updates/update-mdcg-2020-3-rev1-guidance-significant-changes-regarding-transitional-provision-under-article-2023-05-12_en
Update Annex XVI timeline: https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=PI_COM:Ares(2023)3232054

EMDN maintenance project launched: https://www.salute.gov.it/portale/news/p3_2_1_1_1.jsp?lingua=italiano&menu=notizie&p=dalministero&id=6262
Spain: AEMPS and CNCps recognize the need to demonstrate to third parties the validity of expired certificates: https://www.aemps.gob.es/informa/la-aemps-informa-sobre-el-nuevo-procedimiento-del-cncps-para-confirmar-la-validez-de-los-certificados-emitidos-conforme-a-mdd/
Finland: RoHS is also applicable to Medical Devices: https://www.fimea.fi/web/en/-/rohs-act-also-concerns-medical-devices

Training:

Green Belt Certification Program June 26th until June 30th. https://school.easymedicaldevice.com/course/gb26

Switzerland

Incident report for economic operators: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/mu680_20_009d_wl_mdv_vorkommnis_hersteller_mepv.pdf.download.pdf/MU680_20_009e_WL%20Incident%20economic%20operators.pdf
Incident report for users: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/mu680_20_008d_wl-vorkommnismeldung-anwender.pdf.download.pdf/MU680_20_008e_WL%20incident%20report%20user.pdf
Designation of a Vigilance contact person for hospitals: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/mu680_10_007d_wl-vigilance-kontaktperson-medizinprodukte.pdf.download.pdf/MU680_10_007e_WL%20Vigilance%20contact%20person%20for%20medical%20devices.pdf

United Kingdom

New tutorial videos MHRA “How to register medical devices”: https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market
New Regulatory Pathway IDAP: https://www.gov.uk/government/news/new-regulatory-pathway-set-to-support-safe-patient-access-to-innovative-medical-technologies
Assistive Technology: https://www.gov.uk/government/publications/assistive-technology-definition-and-safe-use/assistive-technology-definition-and-safe-use
Report Adverse incidents for Software: https://www.gov.uk/government/publications/reporting-adverse-incidents-involving-software-as-a-medical-device-under-the-vigilance-system/guidance-for-manufacturers-on-reporting-adverse-incidents-involving-software-as-a-medical-device-under-the-vigilance-system

ROW

Australia: Guidance on applying the Advertising Code rules: https://www.tga.gov.au/how-we-regulate/advertising/how-advertise/advertising-guidance/resources/resource/guidance/guidance-applying-advertising-code-rules
Canada: Consultation on proposed amendments to the Medical Devices Regulations and Food and Drug Regulations: https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/medical-devices-compliance-bulletin/consultation-proposed-amendments-medical-devices-food-drug-regulations.html
India: CDSCO updated list of Laboratories for conducting Performance Evaluation of In – Vitro Diagnostic Medical Device  : https://cdsco.gov.in/opencms/opencms/en/Notifications/Public-Notices/

Egypt: European Parliament Decision of March 2023 regarding the transitional grace periods granted in relation to the application of MDR&IVDR rules and procedures: https://www.edaegypt.gov.eg/ar/%D8%A7%D9%84%D9%85%D8%B1%D9%83%D8%B2-%D8%A7%D9%84%D8%A7%D8%B9%D9%84%D8%A7%D9%85%D9%89/%D8%A7%D9%84%D8%A5%D8%B9%D9%84%D8%A7%D9%86%D8%A7%D8%AA/%D9%82%D8%B1%D8%A7%D8%B1-%D8%A7%D9%84%D8%A8%D8%B1%D9%84%D9%85%D8%A7%D9%86-%D8%A7%D9%84%D8%A3%D9%88%D8%B1%D9%88%D8%A8%D9%8A-%D8%A7%D9%84%D8%B5%D8%A7%D8%AF%D8%B1-%D9%81%D9%89-%D9%85%D8%A7%D8%B1%D8%B3-2023-%D8%A7%D9%84%D8%AE%D8%A7%D8%B5-%D8%A8%D8%A7%D9%84%D9%85%D9%87%D9%84-%D8%A7%D9%84%D8%A5%D9%86%D8%AA%D9%82%D8%A7%D9%84%D9%8A%D8%A9-%D8%A7%D9%84%D9%85%D9%85%D9%86%D9%88%D8%AD%D8%A9-%D8%A8%D8%AE%D8%B5%D9%88%D8%B5-%D8%AA%D8%B7%D8%A8%D9%8A%D9%82-%D9%82%D9%88%D8%A7%D8%B9%D8%AF-%D9%88%D8%A5%D8%AC%D8%B1%D8%A7%D8%A1%D8%A7%D8%AA-mdr-ivdr/
Saudi Arabia Webinar:
- Explain The Essential Principles of Safety and Performance for Medical Devices: https://www.sfda.gov.sa/en/workshop/88451
- Risk Management for Medical Devices: ISO 14971 Requirements https://www.sfda.gov.sa/en/workshop/88450

Podcast

Podcast 231: The truth about the UK vs EU situation with Claire Dyson: https://podcast.easymedicaldevice.com/231-2/
Podcast 232: Technical File inconsistencies identified by Notified Bodies with Adam Rae: https://podcast.easymedicaldevice.com/232-2/
Podcast 233: What if your Medical Device company goes bankrupt with Karandeep Badwal: https://podcast.easymedicaldevice.com/233-2/
Podcast 234: How to master Regulatory Intelligence with Ivan Perez Chamorro: https://podcast.easymedicaldevice.com/234-2/

Ask Easy Medical Device. We can help you Contact at info@easymedicaldevice.com

Who is Monir El Azzouzi?

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/
Subscribe to our LinkedIn Newsletter: https://www.linkedin.com/build-relation/newsletter-follow?entityUrn=7051455462466023424

The post Medical Device News -June 2023 regulatory update appeared first on Medical Device made Easy Podcast. hamza benafqir

How to master Regulatory Intelligence?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 30 May 2023 00:00:00 +0000

We all need to keep ourselves up to date. But how to access reliable information and how often should a check be done. This is what we will discuss with Ivan Perez Chamorro from MedBoard. You will get some hints on how to optimize your search.

Regulatory intelligence seems to be a big scary word that people may think it needs a ton of experts to be able to master it. But with digitalization this needs less efforts now. When before you needed to check a lot of journals or visit a lot of country websites, now there are tools that helps you do it quicker. This is mainly the topic of our discussion with Ivan Perez Chamorro from MedBoard.

Who is Ivan Perez Chamorro?

Ivan Perez Chamorro is CEO and Founder of MedBoard, a technology company that organises medical technology information and data, makes it fast accessible to manufacturers and key stakeholders, and it is integrated with breakthrough tools as the Vigilance automation. MedBoard is made up of leading engineers, scientist and medical professionals. This big data platform covers from Regulatory, to Clinical, Market and Technical. Ivan has both strong science and business background, he holds a degree and MSc in Physics from Universidad de Salamanca, and an MBA from IE Business School. Ivan is very active in medical device industry, and he is also part of the TOPRA MedTech SPIN. After having a chronic sports injury while playing basketball, and spending many years in rehabilitation, he decided after physics graduation to work in the medical devices industry. Ivan has lived in different countries and likes travelling, painting, and adventure sports, and has special interest in innovation, entrepreneurship, and technology. MedBoard is not the first project, and Ivan has have a number of entrepreneurship projects in the past, in the medical and outside of medical devices industry. Before Medboard, Ivan had worked for many years within the industry, as an employee of leading medical companies and as a consultant in the areas of product and business development, regulations, and strategy, from operational roles to advising technical and top management. He has broad experience with different types and classes of medical devices and combination products, supporting a variety of organization models, from start-ups to large corporations.

Who is Monir El Azzouzi?

Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, linkedin Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.

Link:

Ivan Perez Chamorro LinkedIn: https://www.linkedin.com/in/ivan-perez-chamorro-804b0b22/
Medboard: www.medboard.com

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post How to master Regulatory Intelligence? appeared first on Medical Device made Easy Podcast. hamza benafqir

What if your Medical Device Company goes Bankrupt?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 23 May 2023 00:00:00 +0000

This is really a difficult situation if your company goes bankrupt. But now the idea is what to do regarding the products that are still on the market. You still have some responsibility and the EU MDR is asking you to put in place some process to anticipate that. This is what we will discuss with Karandeep Badwal today. We’ll try to give you some advice on how to overcome this situation.

Who is Karandeep Badwal?

Karandeep Singh Badwal is an independent Quality & Regulatory consultant within medical devices with a specialism in Software as a Medical Device and Artificial Intelligence having initially started his career within traditional devices working with multi-national companies to small-scale startups. He is also the founder of The MedTech Podcast and regularly makes content around medical devices via LinkedIn and his YouTube channel QRA Medical.

Who is Monir El Azzouzi?

Links from the Video

Karandeep Badwal LinkedIn Profil: https://www.linkedin.com/in/karandeepbadwal/
Karandeep Badwal LinkedIn Profil: https://www.linkedin.com/in/karandeepbadwal
The Medtech Podcat: https://open.spotify.com/show/32CvtseLj3KknqYDFdO7P3
QRA Medical Youtube video: https://www.youtube.com/channel/UC1ygqJO7_HV30XVdHyN-0lg

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post What if your Medical Device Company goes Bankrupt? appeared first on Medical Device made Easy Podcast. hamza benafqir

Technical Files Inconsistencies Identified by Notified Bodies

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 16 May 2023 00:00:00 +0000

This week with Adam Rae we will talk about the Technical Files inconsistency that we noticed while working on some projects. Adam will provide his list of issues like Intended purpose, Clinical Evaluation… So if you want to avoid these issues don’t miss this episode as they can cost you time and money.

Who is Adam Isaacs Rae?

Chartered quality professional with a Master’s Degree focused in Strategic Quality Management from University of Portsmouth. Demonstrated history of working in aerospace & defence, medical device and the construction industry. Skilled in Operations Management, Lean Six Sigma, Failure Mode and Effects Analysis (FMEA), Value Stream Mapping and Supply Chain Management.

Who is Monir El Azzouzi?

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedical…
Instagram: https://www.instagram.com/easymedical…

The post Technical Files Inconsistencies Identified by Notified Bodies appeared first on Medical Device made Easy Podcast. hamza benafqir

The truth about the UK vs EU situation

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 09 May 2023 00:23:15 +0000

Since Brexit, the UK market is really trying to find a way to come back to normal and extract themselve from the EU legislation. They are doing it step by step but for the moment a lot of the products we see are relying on the EU rules. But UKCA is about to be the rule. I mean we thought this will be the rule but apparently there are new timelines coming.

So let’S discuss that with Claire Dyson

Who is Claire Dyson?

Claire Dyson is a seasoned professional in the Med Tech space having spent more than a decade in manufacturing and the last 5 years in certification bodies. She began her career in rational drug design and moved into medical device through devices that interact with drugs and drug-delivery systems. Claire entered certification bodies in 2018 and became Head of UK Approved Body for DEKRA in 2022. She recently resigned and is spending some time creating accessible content to support manufacturers with the regulatory transitions being implemented across Europe. Claire has set up her own company, CAPD Consultancy Ltd, whilst building up a network to help identify the needs across the industry and provide the right type of help that manufacturers need.

Who is Monir El Azzouzi?

Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, youtube videos, linkedin Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.

Link:

Claire Dyson Linkedin page: https://www.linkedin.com/in/claire-dyson-85845b4b/
UK transition timelines: https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk
UK transition rule: https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices-and-extension-of-standstill-period/implementation-of-the-future-regulations

UK medical device regulation: https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk

UK Government’s response to the 2021 consultation outlining the future of UK medical device regulations: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1085333/Government_response_to_consultation_on_the_future_regulation_of_medical_devices_in_theUnited_Kingdom.pdf

Social Media to follow:

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/
Subscribe to our LinkedIn Newsletter: https://www.linkedin.com/build-relation/newsletter-follow?entityUrn=7051455462466023424

The post The truth about the UK vs EU situation appeared first on Medical Device made Easy Podcast. hamza benafqir

Medical Device news – May 2023 Regulatory Update

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Fri, 05 May 2023 01:00:00 +0000

•Team-NB Sector Survey 2022 :https://www.team-nb.org/wp-content/uploads/members/M2023/Team-NB-MD-Sector-Survey-PressRelease-20230411.pdf

• MDCG planning available :https://health.ec.europa.eu/system/files/2023-04/md_events_2023_en_1.pdf •TEAM-NB position paper : https://www.team-nb.org/wp-content/uploads/members/M2023/Team-NB-PositionPaper-BPG-TechnicalDocEU-MDR-2017-745-V2-20230419.pdf

•Finland – Electronic Submission for Medical Devices :https://www.fimea.fi/web/en/-/electronic-submissions-for-medical-devices-will-be-opened-on-2-may-2023

•France- Digital Medical Application reimbursement :https://esante.gouv.fr/espace-presse/lancement-de-la-prise-en-charge-anticipee-des-dispositifs-medicaux-numeriques

• Switzerland – IVD performance studies : https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw600_00_016e_mb_performance_studies_with_ivd.pdf.download.pdf/BW600_00_016e_MB_Information_performance_studies_IVD_KlinVMEP.pdf

•Switzerland – IMDRF OFFICIAL OBSERVER :https://www.swissmedic.ch/swissmedic/en/home/news/mitteilungen/swissmedic-official-observer-imdrf.html

• UK – Transition from CE to UKCA :https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices-and-extension-of-standstill-period/implementation-of-the-future-regulations

• Training EU MDR :https://school.easymedicaldevice.com/course/gb25 oTitle: USA: Draft guidance on PCCP for AI/ML :https://www.fda.gov/media/166704/download o USA: Radiation Sterilization Master File Pilot Program :https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrh-announces-radiation-sterilization-master-file-pilot-program.

o Australia: Regulation for software based medical devices :https://www.tga.gov.au/how-we-regulate/manufacturing/medical-devices/manufacturer-guidance-specific-types-medical-devices/regulation-software-based-medical-devices

o China: Guideline for Medical Device :https://www.cmde.org.cn/xwdt/zxyw/20230404163902154.html o India: List of Notified Bodies registered in India :

o Mexico, Colombia & Cuba sign the Acapulco Declaration : https://www.gob.mx/cofepris/articulos/se-firma-declaracion-de-acapulco-para-creacion-de-la-agencia-reguladora-de-medicamentos-y-dispositivos-medicos-de-latinoamerica-y-el-caribe?idiom=es oSaudi Arabia Webinars :

•May 9, 2023 Guidance on Medical Devices Classification https://www.sfda.gov.sa/en/workshop/88229 •May 22, 2023 Product Sterilization Requirements for Medical Devices https://www.sfda.gov.sa/en/workshop/88228

oPodcast Nostalgia

•Episode 227: What is a SOUP for your Software Development Christian Kaestner Medical Device HQ https://podcast.easymedicaldevice.com/227-2/

•Episode 228: Prepare your Audit like a PRO with Karandeep Badwal https://podcast.easymedicaldevice.com/228-2/

•Episode 229: Transition to Agile for Software as Medical Device: https://podcast.easymedicaldevice.com/229-2/

Ask Easy Medical Device . We can help you

•Contact at info@easymedicaldevice.com

Who is Monir El Azzouzi?

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/
Subscribe to our LinkedIn Newsletter: https://www.linkedin.com/build-relation/newsletter-follow?entityUrn=7051455462466023424

The post Medical Device news – May 2023 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

Transition to Agile for Software as Medical Device

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 25 Apr 2023 01:00:00 +0000

We start to talk more and more of Software as Medical Device or SaMD. This time we will check with you how to develop a Software and transition to the Agile methodology with the company IronRooster.

Waterfall? Agile? … The methodology to develop a Software are multiple but you need as a company to define it prior to the project so you have the right pathway to follow. And in this episode of the podcast we will help you transition to the AGILE methodology for Software development. This is a well known method but we’ll try also to explain its advantages and also look at the way for you to transition to it. Bence and Attila from IronRooster will be my guests and they will tell you the tips an tricks about Agile development

Who is Bence Török?

I am Bence, a proud member of the Iron Rooster team for two years now, spending most of my time trying to improve a MedTech project. I began my journey in the IT field as a technical writer working on Telecommunication projects, but after joining Iron Rooster, I quickly realized that project management was where I wanted to focus. Therefore, I delved into it and continue to expand my knowledge each day. Currently, I manage several MedTech projects and work with excellent software professionals in the blood banking industry, where we cover everything from donor recruiting to laboratory testing.

Who is Attila Katona?

My name is Attila, and I am a senior member of the Iron Rooster team. I have been a long-time (tor)mentor for my merry team of quality assurance and regulatory compliance experts in our medical software development company. Over the years, I have been involved in 50+ projects in half a dozen different roles, performing various roles ranging from requirements engineering and test management to designing complex product documentation processes and full QMS maintenance.

Who is Monir El Azzouzi?

Links from the Video

IronRooster Linkedin page: https://www.linkedin.com/company/ironrooster/
Bence Linkedin Page:
Attila Linkedin Page:
IronRooster website: https://ironrooster.io/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Transition to Agile for Software as Medical Device appeared first on Medical Device made Easy Podcast. hamza benafqir

Prepare your audit like a PRO

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 18 Apr 2023 00:00:00 +0000

If you are selling a Medical Device that is not a class I, then you know that you have to go through an audit with a Notified Body. So let’s discuss how you should be prepared for that with Karandeep Badwal.

An Audit is really an exercise that all Quality and Regulatory people should understand to master it. See it as a performance on stage, or a sport competition. Before it happens, you should prepare yourself. We will discuss on this episode with Karandeep Badwal of the way that you should be preparing and the tips and tricks that you will need to know. Internal audit, CE audi, ISO audit, MDSAP audit, Supplier audit … You’ll have to go through this within many occasions so be ready for it.

Who is Karandeep Badwal?

Who is Monir El Azzouzi?

Links from the Video

Karandeep Badwal LinkedIn Profil: https://www.linkedin.com/in/karandeepbadwal/
Easy Medical Device blog on audit: https://easymedicaldevice.com/internal-audit/
Podcast episode on audit: https://podcast.easymedicaldevice.com/175/
Video on internal audit: https://www.youtube.com/watch?v=UA_J_WXLPag&pp=ygUiZWFzeSBtZWRpY2FsIGRldmljZSBpbnRlcm5hbCBhdWRpdA%3D%3D

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
Subscribe to our LinkedIn Newsletter: https://www.linkedin.com/build-relation/newsletter-follow?entityUrn=7051455462466023424

The post Prepare your audit like a PRO appeared first on Medical Device made Easy Podcast. hamza benafqir

What is a SOUP for your Software Development?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 11 Apr 2023 01:00:00 +0000

In this context SOUP is not a dish but Software Of Unknown Provenance which is the term used for Software that was not created by you. Christian Kaestner from Medical Device HQ will explain to us what you should consider when you have a SOUP within your product.

SOUP is the acronym for Software Of Unknown Provenance. This is mainly a piece of software that you want to use on your Medical Device but that you have not developed yourself. So if you have such a thing, then you need to listen to this podcast episode with Christian Kaestner from Medical Device HQ.

Who is Christian Kaestner?

Christian Kaestner is a highly skilled professional with over 25 years of experience in the medical device field. As a software developer with a deep interest in medical device software, Christian has the technical background to understand software development. Christian was on the project teams that authored IEC 62304 and IEC 82304-1, so he has in-depth experience working with standards. If you’re looking to improve your team’s knowledge and skills, Christian offers online courses through Medical Device HQ to keep you up-to-date with industry best practices. He can also guide you in setting up your development process to comply with relevant standards. Visit medicaldevicehq.com to learn more, and feel free to connect on LinkedIn.

Who is Monir El Azzouzi?

Links from the Video

LinkedIn Christian Kaestner: https://www.linkedin.com/in/christiankaestner/
I’m happy to answer short follow-up questions through LinkedIn messages. Blog post on how to manage SOUPs: https://medicaldevicehq.com/articles/managing-and-documenting-soup-and-ots-in-medical-device-software/ Medical device resources on YouTube: https://www.youtube.com/medicaldeviceHQ
Playlist with medical device software videos on YouTube: https://www.youtube.com/playlist?list=PLHbDOHytLFxGSmU8aiSWXskPN0qZv0VPg
Link to SaMD course: https://medicaldevicehq.com/samd
Eqms SmartEye: https://s-cube.tech/
Authorized Representative: https://easymedicaldevice.com/authorised-representative-and-importer/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
Subscribe to our LinkedIn Newsletter: https://www.linkedin.com/build-relation/newsletter-follow?entityUrn=7051455462466023424

The post What is a SOUP for your Software Development? appeared first on Medical Device made Easy Podcast. hamza benafqir

Medical Device News – March 2023 Regulatory Update

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 04 Apr 2023 02:00:00 +0000

► Medboard platform: https://www.medboard.com/

► Podcast page: https: //podcast.easymedicaldevice.com/226-2/

► MEDBOARD SHOW NOTES LINKS: https://www.medboard.com/reports/easy-medical-device-regulatory-update/2023/april/

Today on this Medical Device news for March 2023 we’ll talk about

• The EU MDR Extension vote https: //health.ec.europa.eu/system/files/2023-03/mdr_proposal_extension-q-n-a.pdf

• The Notified Bodies that are certified https: //www.team-nb.org/frequency-of-complete-re-assessments-of-notified-bodies/

• The changes in EU spain, UK, Switzerland, Belgium https: //www.sfda.gov.sa/sites/default/files/2023-03/MDS-G012A.pdf

• But also Middle East, USA, Brazil. https: //www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2023/consumidor-ganha-plataforma-para-notificacao-de-eventos-adversos

• UDI helpdesk https://webgate.ec.europa.eu/udi-helpdesk/?lang=en

► Who is Monir El Azzouzi?

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► Links from the Video

– https://www.medboard.com/

– Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/

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► Social Media to follow

■ Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

■ Twitter: https://twitter.com/elazzouzim

■ Pinterest: https://www.pinterest.com/easymedicaldevice

■ Instagram: https://www.instagram.com/easymedicaldevice

—————————————————————————————— #easymedicaldevice #medicaldevice #regulatorycompliance

The post Medical Device News – March 2023 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

How to perform Risk Management for a Software ?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 28 Mar 2023 00:00:00 +0000

In this episode, Bijan Elahi will help us perform risk management for SaMD and give us some tips on the best strategies. Bijan is also the author of the book “Safety Risk Management for Medical Devices”.

If you have to perform risk management for a software as a Medical Device or Medical Device software you may think how this can be done?, Are the tools, standards, the same as for normal medical devices? Are the risks different? Bijan Elahi will be my guest on this episode and will explain to us the best practices for SaMD risk management. Don’t miss this and also his book called “Safety Risk Management for Medical Devices”. Link below.

Who is Bijan Elahi?

Bijan Elahi has worked in safety risk management for medical devices for over 25 years at the largest medical device companies in the world, as well as small startups. He started his work in risk management in aerospace; last working on the Space Shuttle at NASA before transitioning to the medical device industry in the early 1990’s.

Bijan is the corporate expert on risk management at Medtronic. In this capacity, he offers education and consulting on risk management to all Medtronic business units worldwide. Bijan is also a lecturer at Delft University of Technology, and Eindhoven University of Technology in the Netherlands, where he teaches risk management to doctoral students in engineering. Bijan is a frequently invited speaker at international professional conferences, and is also a contributor to ISO 14971, the international standard on the application of risk management to medical devices. He is the author of the book Safety Risk Management for Medical Devices.

Who is Monir El Azzouzi?

Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, youtube videos, linkedin Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.

Link:

– Bijan Elahi LinkedIn Profile: https://www.linkedin.com/in/bijanelahi/

– Book: “Safety Risk Management for Medical Devices”: https://books.google.fr/books/about/Safety_Risk_Management_for_Medical_Devic.html?id=UzU4EAAAQBAJ&redir_esc=y

– Episode 207: Why Risk Management is important to Medical Device development: https://www.youtube.com/watch?v=cFmVpYkQ0wk

– Episode 216: How to evaluate Benefit-Risk ratio for Medical Devices?: https://www.youtube.com/watch?v=7fimKKqBtEY
– Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/

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Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post How to perform Risk Management for a Software ? appeared first on Medical Device made Easy Podcast. hamza benafqir

How to create a Proactive Postmarketing Surveillance? [EU MDR]

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 21 Mar 2023 00:00:00 +0000

The EU MDR is requiring more transparency and the PMS has a lot to play in it. In this episode, we will explain to you a difference that is visible for PMS which is Proactive Postmarketing Surveillance. We will explain what they mean by that and how some digital tools can help you.

Who is Marcus Emne?

Marcus Emne is the CEO & founder of Hoodin, the intelligence SaaS for life science & compliance. Marcus has extensive experience in international business from both high tech, software and life sciences. Over the last years, he has had a focus on intelligence and the subdomains Ai, Automation and Machine Learning in relation to regulatory needs within life science. If you wish to get further guidance or discuss RA/QA in relation to Ai, Automations and Machine Learning, feel free to contact Marcus.

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Who is Monir El Azzouzi?

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Links from the Video

Schedule a discovery call: https://rb.gy/nl9ghd
email: marcus@hoodin.com
LinkedIn: https://www.linkedin.com/in/marcusemne/
LinkedIn profile Marcus Emne: https://www.linkedin.com/in/marcusemne/
Hoodin web page: https://www.hoodin.com/
Schedule a discovery call: https://rb.gy/nl9ghd
MDCG PMS 2022-21 https://health.ec.europa.eu/system/files/2023-01/mdcg_2022-21_en.pdf
Easy Medical Device Authorized Representative and Importer service: https://easymedicaldevice.com/authorised-representative-and-importer/

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► Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post How to create a Proactive Postmarketing Surveillance? [EU MDR] appeared first on Medical Device made Easy Podcast. hamza benafqir

What you should know about Vigilance Reporting for Medical Devices?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 14 Mar 2023 00:00:00 +0000

Vigilance Reporting is a process you should have but don’t want to use. In fact not having any vigilance reporting is a sign that your product is doing well. But having one means that maybe you need to improve your device.

So in this episode, we will explain to you what is Vigilance Reporting and how you should build it. We will explain EU reporting, the UK, but also other regions. We will also mention IMDRF guidances that are important.

Who is Adam Isaacs Rae?

Who is Monir El Azzouzi?

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedical…
Instagram: https://www.instagram.com/easymedical…

The post What you should know about Vigilance Reporting for Medical Devices? appeared first on Medical Device made Easy Podcast. hamza benafqir

Medical Device News: March 2023 Regulatory Update

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Wed, 08 Mar 2023 00:00:00 +0000

Here is your Regulatory Update for the month of March 2023.

Check all the links on Medboard Platform: https://www.medboard.com/reports/easy-medical-device-regulatory-update/2023/march/

– EU MDR 2017/745 extension has been voted: https://www.raps.org/news-and-articles/news-articles/2023/2/european parliament-votes-to-extend-mdr-transition

-UK Impact of extension of Medical Device Regulations transitional period and the validity of Certificated in the EU:

https://www.gov.uk/government/news/impact-of-extension-of-medical-device-regulations-transitional-period-and-thevalidity-of-certificates-in-the-eu

-Ireland – Article 97 request form : https://www.hpra.ie/homepage/about-us/publications-forms/forms-applications/item? id=e4cb1326-9782-6eee-9b55-ff00008c97d0

-EU Team-NB. Best practice Guidance for the submission of Technical Documentation for IVDR: https://www.team nb.org/team-nb-pp-best-practice-guidance-for-the-submission-of-technical-documentation-under-annex-ii-and-iii-of-in-vitro diagnostic-medical-devices-regulation/

-EU Team-NB . IVDR technical Documentation training for manufacturers: Wednesday June 14th, 2023 https://www.team nb.org/wp-content/uploads/members/M2023/Leaflet-IVD-TC-Manufacturers-Training-

-EMA pilots scientific advice for certain High-Risk Medical Devices: https://www.ema.europa.eu/en/news/ema-pilots scientific-advice-certain-high-risk-medical-devices

– New Notified Bodies

○ NSAI for IVDR: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id= 321463&version_no=10

○ MDC for IVDR: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id= 321397&version_no=8

-Spain AEMPS: Notice addressed to Notified Bodies and Manufacturers of Nasal Sprays with Virucidal or Microbicidal action: https://www.aemps.gob.es/informa/la-aemps-publica-una-nota-de-aviso-dirigida-a-organismos-notificados-y-a-fabricantes de-esprais-nasales-con-accion-viricida-o-microbicida/

-Swiss – Q&A for IVD notification:

https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw630_30_010d_mb_faq_invitro_diagnostika_meldungen.pdf.download.pdf/BW630_30_010e_MB_FAQ_Notifikationen_IVD.pdf

/search-fda guidance-documents/guidance-industry-and-food-and-drug-administration-staff-assemblers-guide-diagnostic-x ray-equipment

–Performance standard for Diagnostic X-Ray systems. https://www.fda.gov/regulatory-information/search-fda guidance-documents/performance-standard-diagnostic-x-ray-systems-and-their-major components-21cfr-102030-102031-102032

-Medical X-ray imaging devices coformance with IEC Standards: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-x-ray-imaging-devices-conformance-iec-standards

-List of cleared Companion Diagnostic: https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or approved-companion-diagnostic-devices-in-vitro-and-imaging-tools

-US Medsun February 2023: https://www.fda.gov/media/165125/download

-SAUDI-DI Webinar March 20th 2023 https://www.sfda.gov.sa/en/workshop/87814

-Link to Webex: https://zoom.us/j/95729656046?pwd=NmNOLzZYT0hmK3JqVXhPQ25LQmQ5Zz09

-Link to Webex: https://zoom.us/j/93572022832?pwd=K1ZVL2xTNXFHV3NEdXVGbk4yN0Z3Zz09

–South Africa. SAPHRA Q&A on Licensing of Medical Device establishment: https://www.sahpra.org.za/wp content/uploads/2023/02/SAHPGL-MD-07_v3-Guideline-on-Questions-and-Answers-Licensing-of-Medical-Device-

Establishments.pdf

○ Episode 219 – Biological Evaluation: Top Big Mistakes (Paul Fernandes and Laura Fouzari) https://podcast.easymedicaldevice.com/219-2/

○ Episode 220 – SaMD International Reach (Stephane Berger) https://podcast.easymedicaldevice.com/220-2/

○ Episode 221 – Prepare your transition from Class I to Class Ir https://podcast.easymedicaldevice.com/221-2/

○ LinkedIn Live – Samd Class I – To be published this week

► Social Media to follow

■ Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

■ Twitter: https://twitter.com/elazzouzim

■ Pinterest: https://www.pinterest.com/easymedicaldevice

■ Instagram: https://www.instagram.com/easymedicaldevice

The post Medical Device News: March 2023 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

Prepare your transition from Class I to Class Ir

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 28 Feb 2023 00:00:00 +0000

The EU MDR is planning to be really challenging for Class I reusable Surgical Instruments as they will need to move to Class Ir. In this Episode, Tautvydas from Test Labs will explain to us what is expected from Medical Device Manufacturers. What they should prepare for being compliant with the new regulation?

Who is Tautvydas Karitonas?

Tautvydas is focused on accelerating access to the market for medical devices. He has almost a decade of experience developing state-of-the-art products for healthcare, which are now used in hospitals worldwide. Tautvydas provides expertise in product development, validation, and problem-solving.

Who is Monir El Azzouzi?

Links from the Video

LinkedIn profile Tautvydas: https://www.linkedin.com/in/tautvydaskaritonas/
Test Labs webpage: www.testlabsuk.com
MDCG 2020-2 – Class I transition: https://health.ec.europa.eu/document/download/e87d08dc-87ab-49d9-8ffa-5552fa978d14_en
Easy Medical Device Authorized Representative and Importer service: https://easymedicaldevice.com/authorised-representative-and-importer/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Prepare your transition from Class I to Class Ir appeared first on Medical Device made Easy Podcast. hamza benafqir

SaMD international reach – What to consider?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 21 Feb 2023 00:00:00 +0000

We are in a global world, so normally what is good for the EU can be also good for other countries. But here the only barrier is local law. This is mainly what we will discuss on this Podcast. We will use the example of SaMD or Software as a Medical device for it and share with you the experience that we have but this is applicable to nearly all medical devices. Check the podcast page at: https://podcast.easymedicaldevice.com/220-2/

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► Who is Stéphane Berger?

Holder of a diploma in Electronics, with an experience of 25 years in the industry, after 10 years in the semiconductor field service business, he entered the medical device world in an ultrasound imaging company and started to implement ISO13485 requirements as customer service director and operation director. He began his career in quality and regulatory affairs in a recognized Notified Body with a position of auditor specialized in medical devices and software. He is currently holding the position of Regulatory and Quality Affairs Manager at Avicenna.AI, a French start-up that provides artificial intelligence solutions for radiology. Their products are registered in more than 40 countries worldwide and follow the evolving world of regulation around the Artificial Intelligence and Medical Device markets.

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► Who is Monir El Azzouzi?

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► Links from the Video

■ LinkedIn Profile of Stéphane Berger: https://www.linkedin.com/in/bergerstephane

■ Avicenna Website: https://avicenna.ai/

■ WHO listing of Worldwide requirements: https://apps.who.int/iris/rest/bitstreams/1480622/retrieve

■ Authorized Representative Service: https://easymedicaldevice.com/authorised-representative-and-importer/

——————————————————————————————-

► Social Media to follow

■ Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

■ Twitter: https://twitter.com/elazzouzim

■ Pinterest: https://www.pinterest.com/easymedicaldevice

■ Instagram: https://www.instagram.com/easymedicaldevice

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#easymedicaldevice #medicaldevice #regulatorycompliance

The post SaMD international reach – What to consider? appeared first on Medical Device made Easy Podcast. hamza benafqir

Biological Evaluation: Top Big mistakes

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 14 Feb 2023 00:00:00 +0000

In this podcast episode, Laura and Paul will share with us the big mistakes done by some Medical Device manufacturers when they are considering Biological Evaluation for their products.

You may need to take some notes as Laura and Paul are really knowledgeable on this process as they are onboarding some of their customers at ICARE Group and they will share with us the good, Bad, and ugly.

Don’t forget also to check their webpage to see what Icare can provide to you as a service.

Who is Paul Fernandez?

Holder of a Master’s degree in Toxicology and after a brief training in nutrition research, he began his career in regulatory affairs specializing in medical devices at ICARE when the MDR came into force. Curious by nature, and specialized in biocompatibility testing and in biological/toxicological risk analysis, he accompanies and guides many MD manufacturers in their biological evaluation strategy and after audit with authorities. He is currently a referent for the biological and toxicological safety of MD within Groupe ICARE.

Who is Laura Fouzari?

Following a master degree in toxicokinetics and toxicology, LF has specialized in the medical device sector and has started working on these themes for 4 years. Nowadays, she is working as a safety and toxicological safety assessor in the Regulatory Affairs Unit within the Biotox Unit of Groupe Icare.

Who is Monir El Azzouzi?

Medical Device News: February 2023 Regulatory Update

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 06 Feb 2023 23:46:01 +0000

Here is your Regulatory Update for the month of February 2023. Check all the links below

– EU amendment of the EU MDR and IVDR: https://health.ec.europa.eu/medical-devices-sector/new-regulations_en
– Proposal for extension consultation: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13684-Medical-devices-transition-period-extension_en
– Q&A: https://ec.europa.eu/commission/presscorner/detail/en/QANDA_23_24
– General Secretariat: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CONSIL:ST_5585_2023_INIT
– Vote: https://eur-lex.europa.eu/procedure/EN/2023_5?qid=1675093438485&rid=1

– EU Coverage of MDR code: https://health.ec.europa.eu/latest-updates/update-coverage-designation-codes-mdrivdr-notified-bodies-january-2023-2023-01-13_en

– EU list of Standard Fees for Notified Bodies: https://health.ec.europa.eu/latest-updates/mdcg-2023-2-list-standard-fees-january-2023-2023-01-12_en

– EU Delegated directive for exemption for lead as a thermal stabilizer in Polyvinyl Chloride used as base material in sensors used in in-vitro diagnostic medical devices: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13594-Electrical-equipment-lead-in-polyvinyl-chloride-for-sensors-used-in-diagnostic-medical-devices-RoHS-exemption-_en

– MDCG 2023-1 Guidance on the health institution exemption under Article 5(5) of EU MDR and IVDR: https://health.ec.europa.eu/system/files/2023-01/mdcg_2023-1_en.pdf

– Annual overview of devices subject to the clinical Evaluation Consultation Procedure (CECP): https://health.ec.europa.eu/latest-updates/annual-overview-devices-subject-clinical-evaluation-consultation-procedure-cecp-april-2021-june-2022-2023-01-23_en

– Training EU MDR 2017/745: https://school.easymedicaldevice.com/course/gb24

– UK government response to the consultation on Medical Device Regulation: https://www.gov.uk/government/publications/government-response-to-the-rhc-report-on-medical-devices

– UK MHRA increases UK assessment capacity for In-Vitro diagnostic devices: https://www.gov.uk/government/news/mhra-increases-uk-assessment-capacity-for-in-vitro-diagnostic-devices

– Swiss – FAQ on Medical Devices: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw630_30_009d_mb_faq_mep_notifikationen.pdf.download.pdf/BW630_30_009e_MB_FAQ_Notifications.pdf

– Notified Bodies SLG Prüf und Zertifisierungs – 37 – EU MDR https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=321000&version_no=11 https://www.slg.de.com/home.html EU MDR 37: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34 IVDR 8: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=35

– Saudi Arabia: Guidance AI/ML Software based: https://www.sfda.gov.sa/sites/default/files/2023-01/MDS-G010ML.pdf

– Leading Voices in Medtech: https://lnkd.in/eUJcAQxE https://www.linkedin.com/posts/melazzouzi_medtech-easymedicaldevice-medicaldevices-activity-7025727213714997248-plJX?utm_source=share&utm_medium=member_desktop

Podcast episodes:

How to improve the relationship between QA – RA and Marketing?

Breaking News: EU MDR Extension Proposal is out for consultation

How to evaluate Benefit-Risk Ratio for Medical Devices?

How to do Post-Marketing Surveillance in the US (vs EU)?

The post Medical Device News: February 2023 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

How to do Post-Marketing Surveillance in the US (vs EU)?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 31 Jan 2023 00:31:00 +0000

We talk a lot about Post Marketing Surveillance in Europe with EU MDR, MDCG, and all the rules to follow. But when you hear about how this is done in the US you will see that this is really completely different.

For that, I have invited Robert Packard to help us understand the rules behind it and also talk about an IT application that can help you to gather data for your PMS. Let’s review that together.

Who is Robert Packard?

I have 20 years of experience in the medical device industry and another 10 years of experience in biotech manufacturing validation and scale-up. I am a UConn graduate in Chemical Engineering. I was Director of Quality and Regulatory Affairs at four different medical device start-ups, and I was President/CEO of a laparoscopic imaging company I co-founded in 2004. My quality management system expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certifications. From 2009-2012, I was a lead auditor and instructor for BSI – one of the largest Notified Bodies for CE Marking and MDSAP Certification.

Who is Monir El Azzouzi?

Links from the Video

522 Post-Market Surveillance Studies Database: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pss.cfm
Post-Approval Studies (PAS) Database: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pss.cfm
Post Market Management of Cybersecurity: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/postmarket-management-cybersecurity-medical-devices
MAUDE Database: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM
Basil Systems PMS Database Tool: https://basilsystems.com/easy-medical-device/
Webinar on PMS EU and US: https://medicaldeviceacademy.com/post-market-surveillance-webinar/

The post How to do Post-Marketing Surveillance in the US (vs EU)? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

How to evaluate Benefit-Risk Ratio for Medical Devices?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 24 Jan 2023 01:00:00 +0000

The evaluation of the Risk-Benefit ratio is key for Risk Management Files per ISO 14971 or when you build your Clinical Evaluation Report or when you need to define the risk of using a particular technology against another. I mean that risk-benefit evaluation is mainly what helps us to decide that our product is safe and performant.

So on this episode, Naveen Agarwal from Achieve will be my guest and help us understand the best way to measure your benefit-risk ratio.

Who is Naveen Agarwal?

Who is Monir El Azzouzi?

Breaking News: EU MDR Extension Proposal is out for consultation

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 17 Jan 2023 01:00:00 +0000

Finally, a proposal is now available, and we wanted to discuss it and identify if there are any surprises. Erik Vollebregt from Axon Lawyer is helping us understand all this.

This proposal is also under consultation until January 18th, 2023. So don’t miss that as this is tomorrow for those seeing the episode today.

To conclude, this is only a proposal, so this is not approved. We are still waiting for the vote. Without this vote nothing is real.

Who is Erik Vollebregt?

Erik specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software, and the protection of personal data. He is an expert in life sciences regulation at the EU and Dutch level, with a focus on contracts, and regulatory litigation against competent authorities and M&A. Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms. He actively contributes to law and policy development at the national and EU levels via membership in specialized committees at branch associations and the European Commission. Erik also works as an arbitrator in medical device-related disputes and is regularly retained as an expert witness in foreign litigation. Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish. Chambers Europe 2017: Erik is known for his specialism in regulatory work, which covers medical technology, devices, and products as well as biotechnology. Clients confirm his strong capabilities, with one saying “he stands out to me. Whenever I work with lawyers he has been the best, with a solid scientific background. He has the perfect combination of skills and experience.”

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device has become a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.

Links from the Video

Erik Vollebregt Linkedin: https://www.linkedin.com/in/erikvollebregt
Axon Lawyers: https://www.axonlawyers.com/
Book EU MDR: https://medicaldeviceslegal.com/2022/10/27/the-2nd-edition-of-the-enriched-mdr-and-ivdr-is-available-now/ [COUPON CODE: easymedicaldevice10]
Download Decision Tree: https://podcast.easymedicaldevice.com/wp-content/uploads/2023/01/MDR-amendment-flowchart2.pdf
EPSCO Meeting article: https://medicaldeviceslegal.com/2022/12/11/the-epsco-meeting-and-beyond/
Consultation link: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13684-Extension-of-the-transition-period-for-medical-devices_en
Commission proposal: https://health.ec.europa.eu/system/files/2023-01/mdr_proposal.pdf

The post Breaking News: EU MDR Extension Proposal is out for consultation appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

How to improve the relationship between QA – RA and Marketing?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 10 Jan 2023 00:00:00 +0000

In the Medical Device world, you need to work as a team. Sometimes it is really difficult and we will discuss that with Omar M. Khateeb. The relationship between Marketing and QA RA is one of those examples. One is willing to sell creatively and the other is trying to avoid any legal issues. So how should this be balanced? Don’t miss this episode to learn more about how you should interact with other team members within your industry.

Who is Omar M. Khateeb?

Omar is a MedTech marketing and sales professional who founded Khateeb & Co which helps MedTech companies grow their sales pipeline and drive product adoption at scale using social media. Having spent over a decade in disruptive technology ranging from robotics and AI to software, Omar uses his skills around persuasion, technology adoption, and category design to help companies get traction in the market.

Who is Monir El Azzouzi?

Medical Device News: January 2023 Regulatory Update

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 03 Jan 2023 07:46:43 +0000

EU MDR extension
- Implementation of the Medical Device Regulation https://data.consilium.europa.eu/doc/document/ST-15520-2022-INIT/en/pdf
- Provisional Agenda 9th Meeting – Implementation of the Medical Device Regulation (MDR) https://data.consilium.europa.eu/doc/document/ST-15453-2022-INIT/en/pdf
- Implementation of the Medical Device Regulation (MDR): EU MDR Transition Period extension proposal by the European Commission. https://video.consilium.europa.eu/event/en/26353
- Erik Vollebregt Article: https://medicaldeviceslegal.com/2023/01/01/mdr-and-ivdr-outlook-for-2023/
Implementing rolling plan
- Implementation Rolling Plan: Regulation (EU) 2017/745 and Regulation (EU) 2017/746 – Latest update: November 2022 https://health.ec.europa.eu/system/files/2022-12/md_rolling-plan_en.pdf
Borderline manual
- Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 – Version2 – December 2022 https://health.ec.europa.eu/latest-updates/manual-borderline-and-classification-under-regulations-eu-2017745-and-2017746-version2-december-2022-2022-12-15_en
Team NB
- AI act for Notified Bodies – Team-NB Position Paper – The designation of notified bodies under the upcoming Artificial Intelligence Act https://www.team-nb.org/wp-content/uploads/members/M2022/Team-NB%20PositionPaper-AI%20Designation-V1-20221216.pdf
Notified Bodies appointed
- QMD Services GmbH (NB 2962), 8th Notified Body designated under IVDR (EU) 2017/746 https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=320456&version_no=1
- ICIM S.P.A., 36th Notified Body designated under MDR (EU) 2017/745 https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=320256&version_no=12 11:31
UK Approved bodies
- UK Approved bodies. https://www.gov.uk/government/publications/medical-devices-uk-approved-bodies/uk-approved-bodies-for-medical-devices
Training to attend and Books to read
- Green Belt 24th Edition : https://school.easymedicaldevice.com/course/gb24/
- EUDAMED Simplified 28th February 2023: https://eudamed.com/index.php/eudamed-training/
- PRRC Training 28 Feb 2023: https://boumansconsulting.com/prrc-academy-cat/2023-02-28-03-07-in-house-manufacturer-prrc-starter-training/
- Erik Vollebregt Book – easymedicaldevice10 https://medicaldeviceslegal.com/2022/10/27/the-2nd-edition-of-the-enriched-mdr-and-ivdr-is-available-now/
MDCG 2022-17
- MDCG position paper on ‘hybrid audits’ – December 2022 https://health.ec.europa.eu/latest-updates/mdcg-2022-17-mdcg-position-paper-hybrid-audits-december-2022-2022-12-06_en
MDCG 2022-18
- MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of an MDR certificate https://health.ec.europa.eu/latest-updates/mdcg-position-paper-application-art97-mdr-legacy-devices-which-mddaimdd-certificate-expires-issuance-2022-12-09_en
MDCG 2022-19 and 20
- Performance study application/notification documents under Regulation (EU) 2017/746 https://health.ec.europa.eu/latest-updates/mdcg-2022-19-performance-study-applicationnotification-documents-under-regulation-eu-2017746-2022-12-12_en
- Substantial modification of performance study under Regulation (EU) 2017/746 https://health.ec.europa.eu/latest-updates/mdcg-2022-20-substantial-modification-performance-study-under-regulation-eu-2017746-december-2022-2022-12-14_en
MDCG 2022-21
- Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745 https://health.ec.europa.eu/latest-updates/mdcg-2022-21-guidance-periodic-safety-update-report-psur-according-regulation-eu-2017745-december-2022-12-16_en
Switzerland Annex XVI products
- Frequently Asked Questions on medical devices – FAQ MD: Update of the section “Products without medical purpose” https://www.swissmedic.ch/swissmedic/en/home/medical-devices/regulation-of-medical-devices/faq.html
US Product Codes
- Non-Invasive Body Contouring Technologies https://www.fda.gov/medical-devices/aesthetic-cosmetic-devices/non-invasive-body-contouring-technologies
- Augmented Reality and Virtual Reality in Medical Devices https://www.fda.gov/medical-devices/digital-health-center-excellence/augmented-reality-and-virtual-reality-medical-devices
SFDA Classification
- Guidelines for classification of medical devices and supplies https://www.sfda.gov.sa/sites/default/files/2022-12/MDS%E2%80%93G008.pdf
PODCAST nostalgia
- Team-PRRC panel discussion https://podcast.easymedicaldevice.com/210-2/
- Is EU MDR extended? https://podcast.easymedicaldevice.com/211-2/
- Grow your LinkedIn Profile: https://podcast.easymedicaldevice.com/212-2/

The post Medical Device News: January 2023 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Grow your LinkedIn Profile with Karandeep Badwal

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 27 Dec 2022 02:30:00 +0000

Getting some visibility is the key to growing your LinkedIn Profile. And on this episode, we tell you how to be more visible or help build a community. As always you cannot do that alone so we propose you a challenge at the end.

Who is Karandeep Badwal?

Who is Monir El Azzouzi?

Is EU MDR extended? with Erik Vollebregt

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 20 Dec 2022 00:50:00 +0000

On December 9th, 2022, the EU Commission made a proposal to extend the transition period of the EU MDR 2017/745. But some people think this is already done which is not the case.

There was also at the exact moment the publication of the MDCG 2022-18 on Article 97 used to continue placing devices on the market. To clarify all that I have invited Erik Vollebregt from Axon Lawyers to help us understand the situation.

Many things were said, so let’s now debunk all the rumors and provide you with some clear understanding.

Who is Erik Vollebregt?

Erik specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software, and the protection of personal data. He is an expert in life sciences regulation at the EU and Dutch level, with a focus on contracts, and regulatory litigation against competent authorities and M&A. Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms. He actively contributes to law and policy development at the national and EU levels via membership in specialized committees at branch associations and the European Commission. Erik also works as an arbitrator in medical devices-related disputes and is regularly retained as an expert witness in foreign litigation. Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish. Chambers Europe 2017: Erik is known for his specialism in regulatory work, which covers medical technology, devices, and products as well as biotechnology. Clients confirm his strong capabilities, with one saying “he stands out to me. Whenever I work with lawyers he has been the best, with a solid scientific background. He has the perfect combination of skills and experience.”

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device has become a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.

Links from the Video

Erik Vollebregt Linkedin: https://www.linkedin.com/in/erikvollebregt
Axon Lawyers: https://www.axonlawyers.com/
Book EU MDR: https://medicaldeviceslegal.com/2022/10/27/the-2nd-edition-of-the-enriched-mdr-and-ivdr-is-available-now/ [COUPON CODE: easymedicaldevice10]
EPSCO Meeting article: https://medicaldeviceslegal.com/2022/12/11/the-epsco-meeting-and-beyond/
Commission briefing note on EPSCO meeting: https://data.consilium.europa.eu/doc/document/ST-15520-2022-INIT/en/pdf
MDCG 2022-18: https://health.ec.europa.eu/system/files/2022-12/mdcg_2022-18_en.pdf
Easy Medical Device Authorized Representative: https://easymedicaldevice.com/authorised-representative-and-importer/

The post Is EU MDR extended? with Erik Vollebregt appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

MDCG, Team-NB, BVMed & Team-PRRC tell you all about PRRC

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 13 Dec 2022 01:00:00 +0000

Imagine that you have a question to ask the EU Commission, your Notified Body, or any association about being a PRRC. Then this is the episode to listen to. During the Team-PRRC event on November 3 and 4 2022, I was able to record some of the sessions and propose them to you know. Here are the people that were on the panel:

Bassil Akra, Board Member of Team-PRRC association as the facilitator https://www.linkedin.com/in/bassil-akra-2388b84b/
Mario Gabrielli Cossellu – EU Commission https://www.linkedin.com/in/mariogabriellicossellu/
Orla Daly – EU Commission https://www.linkedin.com/in/orla-daly-354128b4/
Francoise Schlemmer – Team-NB https://www.linkedin.com/in/francoise-schlemmer-baa16011/
Christopher Kipp – BVMed https://www.linkedin.com/in/christopher-kipp-b16ba71b1/

And here are the questions answered:

Why a PRRC is needed
Will Notified Bodies issue an NC when manufacturers have no PRRC when they are following the MDD directive?
What does it mean to ensure compliance for a PRRC?
What notified bodies are expecting from PRRC to ensure compliance
Is it the intention of the regulation to put PRRC in Jail?
Can a CEO be a PRRC for its company?
Lake of resources to help manufacturers?
PRRC Training?

Who is Monir El Azzouzi?

Link

Team-PRRC association: https://www.team-prrc.eu/
EU Authorized Representative: https://easymedicaldevice.com/eu-rep/
UK responsible person: https://easymedicaldevice.com/uk-responsible-person/
Swiss representative: https://easymedicaldevice.com/swiss-authorised-representative/
Enic-Naric database: https://www.enic-naric.net/

The post MDCG, Team-NB, BVMed & Team-PRRC tell you all about PRRC appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Medical Device News – December 2022 Regulatory Update

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 06 Dec 2022 07:29:58 +0000

HOT TOPICS

Europe

Common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745

Reclassification of groups of certain active products without an intended medical purpose

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32022R2347

Updated information pack for candidate EU reference laboratories published

https://health.ec.europa.eu/latest-updates/updated-information-pack-candidate-eu-reference-laboratories-published-2022-11-30_en

51th CAMD Meeting Statement (The European Competent Authorities for Medical Devices (CAMD))

https://www.camd-europe.eu/other/51th-camd-meeting-statement/

MDCG 2022-16: Guidance on Authorised Representatives Regulation

https://health.ec.europa.eu/system/files/2022-10/mdcg_202216_en.pdf

New Notified Body EU MDR: INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s (Czech Republic)

https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=320100&version_no=24

Training

December 12th until December 16th https://school.easymedicaldevice.com/product/gb

UK MHRA: Borderline products: how to tell if your product is a medical device: New section added ‘Risk classification of medical devices’

https://www.gov.uk/guidance/borderline-products-how-to-tell-if-your-product-is-a-medical-device#risk-classification-of-medical-devices

Swissmedic: Plan to accept FDA products in Switzerland

Finland: Power blackouts do not require special preparedness measures from the users of medicines and medical devices

https://www.fimea.fi/web/en/-/power-blackouts-do-not-require-special-preparedness-measures-from-the-users-of-medicines-and-medical-devices

Rest of the world

United States: EUA Template for Developers of Antigen Diagnostic Tests (MonkeyPox)

https://www.fda.gov/medical-devices/emergency-use-authorizations-medical-devices/monkeypox-emergency-use-authorizations-medical-devices#templates

United States: MedSun Newsletter – November 2022

https://www.fda.gov/media/162771/download

Canada: List of recognized standards for medical devices:

https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/medical-devices/standards/list-recognized-standards-medical-devices-guidance/list-recognized-standards-medical-devices-guidance.pdf
Interesting as ISO 13485:2016 is not included.

Canada: November 8, 2022 updates to list of medical devices for mandatory shortage and discontinuation reporting

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/medical-devices-compliance-bulletin/11-08-changes-reporting-medical-device-shortage.html

Bahrain: Reminder Regarding Deadline for Medical Devices and Supplies Authorized Representatives Registration

https://www.nhra.bh/Media/Announcement/MediaHandler/ImageHandler/documents/Announcements/Announcement2022_Circular No. (35) 2022_To Medical Devices Importers and Suppliers_Deadline for Medical Devices Supplies Authorized Reps Registration_20221124.pdf

If you are looking for an Authorized Representative or Importer in the European area, contact us at EO@easymedicaldevice.com

PODCASTS:

The post Medical Device News – December 2022 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

How to choose the best Sterilization Method for Medical Devices?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 29 Nov 2022 00:00:00 +0000

Sterilization for medical devices is a critical topic. Now when you are developing your Medical Device, you should start by asking which sterilization process you should follow for your devices because this will lead to the question of which material you should use to build your device… So to help us have a clear understanding of how Sterilization should be defined for your medical devices, I have invited Jane Scally from Trinzo.

Who is Jane Scally?

Jane has supported medical device manufacturers around the world in the areas of quality management systems, remediation, strategic growth and planning, M&A due diligence and integration management, MDR transition, biocompatibility, and sterilization. Jane has Notified Body experience, performing QMS site audits in tandem with technical documentation reviews. These activities supported manufacturers maintaining their certification under the Directives and those transitioning to MDR 2017/745. Jane holds a Bachelor of Science in Applied Biology and Biopharmaceutical Science, a Higher Diploma in Pharmaceutical Business, and a Master of Science in Medical Technology Regulatory Affairs.

Who is Monir El Azzouzi?

Why Risk Management is important to Medical Device development?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 22 Nov 2022 00:00:00 +0000

Risk Management is a discipline of its own within the Medical Device field. In ISO 13485, EU MDR 2017/745, IVDR 2017/746, FDA QSR, MDSAP… All of them talk about Risk Management. You should manage your risks. But why is this so important or even critical? This is what we will discuss with Kailash Kalidoss who is a Medical Device Engineer and also a NASA Ambassador. He will share with us his experience.

PS: if your company needs an EU, UK or Swiss Authorized representative or Importer, don’t hesitate to contact Easy Medical Device. See the link below.

Who is Kailash Kalidoss?

The foundation of my professional experience is in consulting for complex MedTech projects, from conceptualization to product release. In my 13+ years of experience, I have worked as a Design control consultant for various leading US-based Medical Device Companies. I’m also certified by AAMI for Medical Quality System Regulations. Currently, I work for a cutting-edge engineering consulting firm based out of the Bay area in California. Academically my career is well rounded with an MBA from a prestigious B-School. Also, I have good exposure to STEM fields through MS and Engineering Bachelor degrees earlier, to effectively complement the B-School erudition. SPECIALITIES: Medical Device Design Control, Verification, and Validation, Software in Medical Devices and SaMD, Quality, Medical Device Regulations BEYOND WORK: Aerospace Educator for Civil Air Patrol, a United States Airforce Auxiliary. NASA Solar System Ambassador.

Who is Monir El Azzouzi?

Regulatory Pathway: How to reach the US market? [510k exempt]

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 15 Nov 2022 00:00:00 +0000

You maybe ask yourself how to get to distribute your Medical Device in the US? Then listen to the story of MysteryVibe with their devices. He will answer questions such as: – Why the US market and not the EU? – What was the interaction with consultants for the Quality and Regulatory aspects? – How is it to work with a Quality Management System? – How is the logistic of the product working? – Why perform Clinical Investigations? So I hope this will help you understand the market by listening to the MysteryVibe Journey.

Who is Dr.Soumyadip Rakshit?

Dr. Soum Rakshit is the Co-Founder & CEO of the award-winning sexual health company, MysteryVibe. Their mission is to make sexual health accessible to all – across all ages, genders & orientations. In his role as CEO of MysteryVibe, he focuses on pushing the boundaries on R&D, and customer experience and supporting their long-term goal of making sexual health an integral part of our overall health. Soumyadip passionately believes that by empowering people with actionable knowledge & purposeful innovation is the way to make this happen. Soumyadip built and sold his first startup in defense electronics by age 26, and has won 20+ International design awards for his product designs.

Who is Monir El Azzouzi?

Your Software/IVD clinical report is completely WRONG!

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 08 Nov 2022 00:00:00 +0000

In this episode, Cesare Magri from 4BetterDevices will explain to us why medical device manufacturers are making mistakes when they try to gather Clinical Evidence for their Software or IVD devices.

You may have made also this mistake and it would be better to know that before your Notified Body rejects your application.

You will understand how to solve that and get some advice from Cesare.

Who is Cesare Magri?

Cesare has a mixed Background: Physics and Neuroscience, Ph.D. in Informatics. He worked as a biostatistician at Max Planck in Tübingen and started working with medical devices and clinical evaluations in 2013. He founded be-on-Clinical together with Stefan Bolleininger in 2020. And recently, created the CRO 4BetterDevices.

Medical Device News – November 2022 Regulatory Update

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 01 Nov 2022 01:00:00 +0000

This month we will have some updates on:

Annex XVI
ACRAS Event
MDCG Agenda
Commission Contact update
Team-NB position paper on Off-label use
Team-NB position paper on Cybersecurity
New Notified Body for EU MDR
Notified Body survey
MHRA 12-month extension
MHRA’s new Vigilance system
Swiss Medtech proposal
Team-PRRC annual meeting
USA Medsun
Malaysia training on Good Distribution Practices
China Medical Device Recall
EU MDR training
EUDAMED training
PRRC Training
Book to buy
Podcast episodes of the month.

Enjoy!

Who is Monir El Azzouzi?

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Medical Device News – November 2022 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Can you go to Jail as a PRRC? [Elem Ayne]

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 25 Oct 2022 01:00:00 +0000

We are starting to get more and more questions on the PRRC and I think this episode will help you a lot to understand what your responsibility is when you sign a contract as PRRC. In this episode, I will talk with Elem Ayne, President of Team-PRRC. We will look at the questions that this association is receiving. We will also discuss the first Team-PRRC conference and what will be talked about during that event. Join us if you are in the region.

Who is Elem Ayne?

Elem AYNE is a Quality & Regulatory Affairs Consultant and a member of the “DM Experts” network (in France). She started her career in R&D in microbiology, oncology, and biochemistry. She obtained 2 degrees in Business Development from 2 different Business Schools, then worked in several fields such as purchasing, supply chain, sales, marketing, quality, and regulatory affairs for different industries, in particular in sterilization. She has finally specialized in Regulatory affairs working especially in Class I reusable granted a Master’s degree in this field before founding her own company “ACR Medical” to support manufacturers in their compliance with MDR (EU) 2017/745. She is also the President of the Non-for-profit association Team-PRRC

Who is Monir El Azzouzi?

Links from the Video

Elem Ayne Linkedin: https://www.linkedin.com/in/elemayne
Team-PRRC event (non members): https://www.team-prrc.eu/collect/description/254458-u-team-prrc-annual-summit-event-in-brussels-in-3-4-november-2022-for-public
Special price for members with this link: https://lnkd.in/ejHBcHDH
Team PRRC event Program here: https://www.team-prrc.eu/
How to become the best PRRC ever? https://podcast.easymedicaldevice.com/198/
How to become a PRRC? https://podcast.easymedicaldevice.com/84

The post Can you go to Jail as a PRRC? [Elem Ayne] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

How to be MDSAP certified for your Medical Devices?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 18 Oct 2022 01:00:00 +0000

Within this episode, I will explain to you how you can be MDSAP certified for your Medical Devices. The agenda for this episode is the following:

What is MDSAP?
Which countries are included in MDSAP?
Standards and legislation requirements
How to integrate MDSAP into your QMS?
Who can audit you for MDSAP?
How to verify that you are MDSAP-ready?

Don’t hesitate to check the links below to find more resources to help you.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and notably Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of Medical Device Regulations all over the world. He has now built the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device has become a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.

Medical Device News – October 2022 Regulatory Update

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 11 Oct 2022 00:30:00 +0000

Here is your Regulatory update. Don’t forget to check the show notes for all the links we will mention on this video.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… Is company are also acting as Authorized Representative for EU, UK and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.

Links from the Video

Medboard regulatory links to the episode: https://www.medboard.com/reports/easymedicaldevice/regulatory-update/
TRAINING EU MDR: https://school.easymedicaldevice.com/course/gb21
Episode 197 – US importer with Stéphen Toupin https://podcast.easymedicaldevice.com/197
Episode 198 – How to become the best PRRC ever with Ronald Boumans https://podcast.easymedicaldevice.com/198
Episode 199 – How to select your Notified Body and understand the full process https://podcast.easymedicaldevice.com/199
Episode 200 – Feedback from followers, stakeholder and customers. https://podcast.easymedicaldevice.com/200

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Medical Device News – October 2022 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

What do Clients, Followers, Team, … think of Easy Medical Device?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 04 Oct 2022 00:00:00 +0000

This week, we reached 200 episodes of the Podcast and I asked some of the stakeholders to share feedback on how this helped them achieve their objectives. I also asked some of my team members to tell me what their journey was since they are part of the team.

So today, this is the result of the feedback and I also wanted to thank all the listeners as this journey would not have been achieved without you. Thanks for your comments, and your nice messages.

So let’s meet who is behind Easy Medical Device as I am not alone.

Link

Alex Despotovic Linkedin: https://www.linkedin.com/in/alex-despotovic
Joanna Sandek Linkedin: https://www.linkedin.com/in/joanna-s-95524b10b/
Anindya Mookerjea Linkedin: https://www.linkedin.com/in/anindya-mookerjea-6b5367209
Cesare Magri Linkedin: https://www.linkedin.com/in/cesare-magri-92465345
Ivan Perez Chamorro Linkedin: https://www.linkedin.com/in/ivan-perez-chamorro-804b0b22
Cristina Miroescu Linkedin: https://www.linkedin.com/in/cristina-miroescu-4255a6164
Larina Olteanu LinkedIn: https://www.linkedin.com/in/larina-olteanu-505001216
Odelia Zerbiv Linekdin: https://www.linkedin.com/in/odelia-zerbiv-a569484
Lenny Tonnang: https://www.linkedin.com/in/lenny-t%C3%B6nn%C3%A4ng-23b55a64/
Create an intended purpose with Cesare Magri: https://podcast.easymedicaldevice.com/65
EU MDR lesson learned on clinical data with Cesare Magri: https://podcast.easymedicaldevice.com/171/
eQMS with Anindya Mookerjea: https://podcast.easymedicaldevice.com/182
Scube-Technologies Smarteye eQMS: https://scube-technologies.com/contact/

The post What do Clients, Followers, Team, … think of Easy Medical Device? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

How to select your Notified Body and understand the full process?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 27 Sep 2022 00:00:00 +0000

The selection of Notified Bodies in Europe can be a real challenge and I will explain to you in this Podcast episode how to do it so you can understand the process and get the real outcome for your projects.

There are 33 Notified Bodies for EU MDR 2017/745 at the time of this podcast. This is lower than the number of Notified Bodies that were under EU MDD 93/42/EC so this means that there will be a big bottleneck. So let us help you go over it and really make the right decisions.

To get all the information about this process with Notified Bodies, go to the Annex VII of the EU MDR and IVDR

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company is also acting as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.

How to become the best PRRC ever? [Ronald Boumans]

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 20 Sep 2022 00:00:00 +0000

Becoming the best PRRC ever is something that all PRRC should go for. The PRRC role is really important to avoid some situations that happened like the PIP scandal or recently the Philips issue.

PRRC means Person Responsible for Regulatory Compliance and this is a mandatory role within the Medical Device industry. So if you still have no PRRC within your company then this can be a problem. So learn more about it.

Ronald Boumans will help us understand what should we do to become the best PRRC ever.

Who is Ronald Boumans?

Ronald Boumans has seen the medical devices field from almost every corner thinkable (R&D, distribution, research, certification, standard development, market surveillance, policy making, stakeholders representation, and consulting), so he can approach most challenges from multiple angles. This helps the organizations he works with to adapt their approach to their challenges and keep full control over their processes. The ability of thinking out of the box is a precious added value in the field of regulatory compliance. Graduated as an engineer in industrial design at the Technical University of Delft in 1986, Ronald started his career in R&D for medical devices (including package design). He then moved to importing and distributing devices in The Netherlands, followed by quality research and rearch into the relation between medical devices and quality of life. This brought him to work for the Dutch competent authority as a senior inspector for medical technology. In 2013 he became a senior regulatory consultant at Emergo. In 2022 he started his own consulting company.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.

Links from the Video

Boumans Regulatory Consulting website: https://boumansconsulting.com/
Ronald Boumans LinkedIn: https://www.linkedin.com/in/ronald-boumans-34790055/
Team-PRRC Annual Meeting: https://www.team-prrc.eu/collect/description/254458-u-team-prrc-annual-summit-event-in-brussels-in-3-4-november-2022-for-public
Team-PRRC website: https://www.team-prrc.eu/page/1111392-presentation
PRRC Video LinkedIn Live: https://www.youtube.com/watch?v=RHRI9UjEdjs

The post How to become the best PRRC ever? [Ronald Boumans] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Why do you need an Initial Importer for the US Market?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 13 Sep 2022 00:20:00 +0000

You get a call from the US Customer border which are telling you that your products are blocked. Why that? Maybe because you have no importer defined for these products. And this is what we will explain to you today on this podcast episode. Stéphen Toupin from Dawa Medical is helping those manufacturers by being their Initial Importer and he will tell you what you should do to remain compliant.

Who is Stéphen Toupin?

Over the last 27 years, Stéphan has gained a wealth of experience in the Medtech and pharmaceutical industries with Astra Zeneca, Biovail, and Novo Nordisk. Stephan founded Dawa Medical in 2015 to collaborate with foreign MedTech manufacturers to enter and succeed in the massive US market. Dawa Medical is a United States Initial Importer and FDA agent, with warehousing and distribution capabilities. Dawa Medical also offers services for the Canadian and Latin American markets.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and notably Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He has created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.

Medical Device News: September 2022 Regulatory Update

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 06 Sep 2022 02:50:00 +0000

Here are the links to the Regulatory Updates

HOT TOPIC

EUDAMED Timeline https://health.ec.europa.eu/system/files/2022-07/md_eudamed_timeline_en.pdf
EU Call for application submission of EU Reference laboratories. https://health.ec.europa.eu/latest-updates/call-eu-reference-laboratories-sent-member-states-2022-08-05_en
- HPRA & Spain – EU Commission call for Member states application of EU Reference labs for IVDs (EURLs) – http://www.hpra.ie/homepage/medical-devices/news-events/item?t=/european-commission-publishes-call-for-european-union-reference-laboratories-for-ivds-designation&id=619f1226-9782-6eee-9b55-ff00008c97d0
- https://www.aemps.gob.es/informa/notasinformativas/productossanitarios/2022-ps/instrucciones-para-la-presentacion-de-solicitudes-de-designacion-de-laboratorios-de-referencia-de-la-ue-para-productos-sanitarios-de-diagnostico-in-vitro/
- Belgium FAMHP: https://www.famhp.be/en/news/call_for_belgian_laboratories_to_apply_to_become_the_european_union_reference_laboratory_for –
Clinical Evaluation Consultation Procedure
- CECP Class III implantable tricuspide valve procedure https://health.ec.europa.eu/latest-updates/expert-decision-and-opinion-context-clinical-evaluation-consultation-procedure-cecp-2022-08-24_en
- CECP 2022-000213 Transcatheter heath valve https://health.ec.europa.eu/document/download/3ed8dacb-2b9d-4096-bc84-0b408f8492c4_en?filename=cecp-2022-000213_opinion_en.pdf
Draft Reclassification of Annex XVI products https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12972-Medical-devices-reclassification-of-products-without-an-intended-medical-purpose_en
ROW

China – Guidance for registration of percutaneous Enteral Nutrition Catheter and Disposable Human Arterial Blood Samplers https://www.cmde.org.cn/flfg/zdyz/zqyjg/zqyjgwy/20220826111515137.html
India: List of certified Medical Device Testing Laboratories under MDR 2017 https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODg4Mg==
Australia TGA – Regulatory Guidelines for Medical Devices https://www.tga.gov.au/resources/resource/guidance/australian-regulatory-guidelines-medical-devices-argmd

TRAINING

Green Belt Session 20: https://school.easymedicaldevice.com/product/gb/
Scube Technologies: https://scube-technologies.com/

NOTIFIED BODIES

32nd NB MDR – Bureau Veritas Italia https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=318721&version_no=15

GUIDANCES

MDCG 2022-13 – Designation, re-assessment and notification of conformity assessment bodies and notified bodies https://health.ec.europa.eu/document/download/27f91dc2-b5bc-44f9-a975-5024ce3ea556_en?filename=mdcg_2022-13_en.pdf
MDCG 2022-14 Transition to the MDR and IVDR: https://health.ec.europa.eu/system/files/2022-08/mdcg_2022-14_en.pdf

EASY MEDICAL DEVICE PODCAST

Medtech Europe Forum Interview https://podcast.easymedicaldevice.com/188/
AI Act Erik Vollebregt https://podcast.easymedicaldevice.com/189/
Cleanroom Philippe Bourbon Icare https://podcast.easymedicaldevice.com/190/
How to create a Technical File https://podcast.easymedicaldevice.com/191/
When you think 510k but FDA says DeNovo with Spencer Jones Lineus Medical https://podcast.easymedicaldevice.com/192/
Discontinuation process with Alexandros Savvidis https://podcast.easymedicaldevice.com/193/
New Blue Guide Erik Vollebregt https://podcast.easymedicaldevice.com/194/
SaMD and SiMD Design Dossier Anindya Mookerjea https://podcast.easymedicaldevice.com/195/

The post Medical Device News: September 2022 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

SaMD or SiMD – How to create your Design Dossier?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 30 Aug 2022 00:00:00 +0000

If you have developed a Software and you discover that it is considered a Medical Device, then what to do? Or your Software is inside a Medical Device so is this different than normal Medical Devices? In this episode with Anindya Mookerjea from Scube-technologies, we will explain to you the step that you need to follow to create a Design Dossier for your product. This is an important step as this is required for certification by the authorities. So let’s dig into it.

Who is Anindya Mookerjea?

Anindya is the founder and CEO of S-Cube Technologies. He has over 20 years of experience in the medical device & Software industry. Experienced in taking medical device concepts through design & development, regulatory submission, and to market. Expert in the design, development, and implementation of FDA/ISO compliant quality management systems for Medical devices & Software medical devices. Industry expert in Agile methodology implementation for Software medical devices. Strong background in testing Software medical devices. The brainchild of SmartEye product.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company is also acting as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.

Links from the Video

Anindya Mookerjea Linkedin Profile: https://www.linkedin.com/in/anindya-mookerjea-6b5367209/
SCube Technologies website: https://scube-technologies.com/
SCube Technologies Linkedin Page: https://www.linkedin.com/company/scube-technologies/
Twitter account: https://twitter.com/scubetechno
Facebook account: https://www.facebook.com/i.scubetechnologies
Article Medical Device development: https://easymedicaldevice.com/medical-device-development/

The post SaMD or SiMD – How to create your Design Dossier? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

New Blue Guide – What is the impact on Medical Devices?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 23 Aug 2022 01:00:00 +0000

The new Blue Guide is out. So what are the changes for Medical Device Manufacturers? Erik Vollebregt will give us his analysis and also some revelation on the Swiss MRA process if you are still in need of the situation in Switzerland.

Who is Erik Vollebregt?

Erik specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software, and personal data protection. He is an expert in life sciences regulation at the EU and Dutch level, with a focus on contracts, and regulatory litigation against competent authorities and M&A. Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms. He actively contributes to law and policy development at the national and EU levels via membership in specialized committees at branch associations and the European Commission. Erik also works as an arbitrator in medical devices-related disputes and is regularly retained as an expert witness in foreign litigation. Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish. Chambers Europe 2017: Erik is known for his specialism in regulatory work, which covers medical technology, devices, and products as well as biotechnology. Clients confirm his strong capabilities, with one saying “he stands out to me. Whenever I work with lawyers he has been the best, with a solid scientific background. He has the perfect combination of skills and experience.”

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He has created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… Is company is also acting as Authorized Representative for the EU, UK, and Switzerland? Easy Medical Device has become a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.

Why are we not Discontinuing your Products?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 16 Aug 2022 01:00:00 +0000

This is really a good question. Sometimes, we are looking at the portfolio of some companies and ask “How many products on this portfolio are sold in less than 5 units per year” One company with 1200 references showed me an excel sheet with 500 references that are available but with really low volume of sales. This cost stock, regulatory update work, continuous improvement… So let’s talk with Alexandros Saavidis about Discontinuation and I hope this will convince you to embrace this practice.

Who is Alexandros Savvidis?

Alexandros Savvidis is a Senior Medical Device Specialist active for more than 17 years in multiple areas including Regulatory Affairs, Quality Management, R&D, Sales, Technical Support & Analysis. After his studies in Biomedical Engineering, he has worked in the medical devices as also the pharma packaging industry across Europe in Germany, Switzerland, Netherlands, UK, and Greece. He has organized and contributed as an RA Specialist to various successful international certifications of medical devices of all classes. Alexandros has gained one overall experience and deep understanding through his various roles in the full norm compliant development and certification process, like many other aspects like GMP, quality, risk management, vigilance, or clinical evaluations. He has worked on small, middle-size companies alone or as a team member, or even on cross-functional teams of Life Science Giants. In the last years, his main focus is the implementation of MDR requirements and updates

Who is Monir El Azzouzi?

Link

Discontinuation process Download: https://mailchi.mp/easymedicaldevice/discontinuation
Alexandros Linkedin Profile: https://www.linkedin.com/in/alexandrossavvidis/

The post Why are we not Discontinuing your Products? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

When you think “510k” but FDA says “DeNovo” with Spencer Jones

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 09 Aug 2022 00:00:00 +0000

This episode will explain to you the journey of the company Lineus Medical when they tried to register their products in the USA. Initially, they prepared the product to be registered with the 510k Regulatory Pathway but the FDA did not agree and said that they should go through DeNovo. So Spencer Jones who founded the company will tell us how they have done that and he will also give some tips on how he would have done it today if he had to restart again. So benefit from his journey to learn how you should do it.

Who is Spencer Jones?

Spencer worked for three years in direct patient care as a Certified Nursing Assistant, Licensed Practical Nurse, and as a Registered Nurse. Frustrated with the inefficiencies plaguing the healthcare system, he was determined to improve the delivery of healthcare. While still working as a nurse in the clinical setting, Spencer identified opportunities where improvement was needed around IV complication prevention. This led to the creation of SafeBreak® Vascular and the founding of Lineus Medical in 2015. Spencer graduated from the University of Arkansas with a Bachelor in the Science of Nursing. Spencer is on the Fayetteville Innovation Council and was the Entrepreneur in Residence for the Hub X Life Sciences Accelerator for 2016. He has three issued U.S. patents and several others pending.

Who is Monir El Azzouzi?

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post When you think “510k” but FDA says “DeNovo” with Spencer Jones appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

How to create your Technical Documentation? [EU MDR and IVDR]

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 02 Aug 2022 00:00:00 +0000

The creation of a Technical File or Technical Documentation for CE marking is really a challenge sometimes. After successfully passing audits with my customers, I want to share with you some best practices to create your Technical Documentation. I will even explain to you how to reference your annexes or what to do with the GSPR. So don’t miss it.

Who is Monir El Azzouzi?

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post How to create your Technical Documentation? [EU MDR and IVDR] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Maybe you need a Cleanroom? Let’s check with Philippe Bourbon

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 26 Jul 2022 00:00:00 +0000

Cleanroom is an equipement that a lot of Medical Device manufacturer need to have. But do you really need it? How much does it cost? How to qualify it? How to maintain it? Philippe Bourbon from Groupe Icare Laboratory will help us understand all that. Check also the summary provided as a download.

Who is Philippe Bourbon?

Physician, passionate about topics related to particulate, microbiological and chemical contamination on industrial sites and health sectors. 30 years of experience, knowledge in a Cofrac and cGMP / BPF environment, Consulting / Training, Expert in contamination control, and sterilization processes, Sales, Technical Developments, Management of technicians, managers and salespeople , Activity Manager. Expertises: Sterilization by heat, S.I.P., Ethylene oxide, depyrogenation, cleanrooms and controlled environment, microbiological and chemical confinement, climatic and thermostatic chambers, compressed gas Pharmaceutical Regulation (GMP / cGMP), Medical Devices, Standards (ISO14644, ISO17665, FDX15-140, …) Diagnosis / Consulting / Validation strategy / Qualifications / Audits / Trouble shooting

Who is Monir El Azzouzi?

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Maybe you need a Cleanroom? Let’s check with Philippe Bourbon appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

AI Act vs EU MDR 2017/745 are they compatible? [Erik Vollebregt]

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 19 Jul 2022 00:00:00 +0000

If you are working in the development of Software, then this is maybe something that will be interesting for you. The EU is preparing legislation for Artificial Intelligence and we will talk with Erik Vollebregt about the potential compatibility with the EU MDR 2017/745 This new legislation is not focused on Medical Devices but on all software that may contain AI. So if you are impacted, learn what will maybe come within your scope soon.

Who is Erik Vollebregt?

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses… Recently, Monir is becoming a partner of Scube Technologies for the creation of the eQMS Scube SmartEye specialized for Medical Device companies. Check the link below.

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post AI Act vs EU MDR 2017/745 are they compatible? [Erik Vollebregt] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Medtech Europe Forum interviews (MDR, EUDAMED, CER & MECOMED)

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 12 Jul 2022 02:50:00 +0000

During my visit to the Medtech Europe Forum in Barcelona in May 2022, I had the chance to interview key people in the industry. I am sharing these interviews:

Fabien Roy is sharing with us his experience as a lawyer with Notified Bodies.
Peter O’Blenis has introduced me to his software Distiller SR and I had the chance to get a DEMO which was really great
Ronald Boumans explained to me the possible opportunity that can carry EUDAMED for industries
Inna and Rana from Mecomed were also at the conference which was the occasion to get introduced to this organization equivalent to Medtech Europe but in the Middle East.

All the LinkedIn links are below.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand the Medical Device Regulations worldwide. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses… Monir is also a partner with the project Scube Smarteye which developed an eQMS specific for the Medical Device industry. Check the link below.

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Medtech Europe Forum interviews (MDR, EUDAMED, CER & MECOMED) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Medical Device News – July 2022 Regulatory Update

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 05 Jul 2022 02:00:00 +0000

This month the Regulatory update will contain a lot regarding Artificial intelligence for medical devices. All the links that are mentioned can be downloaded from the link below. Don’t hesitate to contact Easy Medical Device if you have a question on Quality and Regulatory Affairs for medical devices.

Who is Monir El Azzouzi?

Links from the Video

Download the July 2022 Regulatory Update document: https://mailchi.mp/easymedicaldevice/july2022

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Medical Device News – July 2022 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Attention! 1 year before UKCA is the law for Medical Devices in the UK

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 28 Jun 2022 00:00:00 +0000

This episode will alert you about the UKCA deadline for the UK market. So if you are selling products to the UK or if you plan to, you need to listen to what Adam Rae will tell you.

We will mention the rules for UKCA, the documentation needed for the Approved Body situation, and also the Northern Ireland Situation.

So no need to read all the regulations, we will summarize the situation here and you will need to act immediately after that.

Who is Adam Rae?

Who Is Monir El Azzouzi?

Why is it great for Importers to be ISO 13485 certified? [Cristina Miroescu]

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 21 Jun 2022 00:00:00 +0000

When we think of ISO 13485 certificate we mainly associate it with Medical Device manufacturers. But this can be also associated with other Medical Device Economic Operators.

In this episode, Cristina Miroescu (Compliance Director at Sofmedica) will explain to us why Sofmedica decided to be ISO 13485 certified. You’ll hear about their journey with the Plus and Minus. We are sure this may help you understand the process of certification if you are an importer or distributor.

Who is Cristina Miroescu?

Cristina joined SofMedica in 2000 as the first regulatory person preparing files for medicinal product and medical devices registration. Later on, as Regulatory Manager her role was to integrate the legal provisions and regulations into the company’s business strategy.

She used to manage quality management systems, vigilance, pharmacovigilance, regulatory, compliance, and warehouse management. As a Group Compliance Director Cristina is responsible to ensure the compliance of the company’s activity with the applicable legislation and requirements with a focus on contributing to building a quality culture of integrity, transparency, and honesty.

An important part of Cristina’s activity was focused between 2010 – 2015 in the medical services field in another company of SofMedica group when she was managing the quality management system, permits obtaining and maintenance for 15 dialysis centers in Romania. Cristina holds a bachelor’s degree in Pharmacy.

Who is Monir El Azzouzi?

What are some Quality Common Mistakes? [Karandeep Badwal]

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 14 Jun 2022 02:00:00 +0000

In this episode, Karandeep Badwal will introduce you to the common mistakes that we can see within your company for Quality and Regulatory affairs:

Software validation
Supplier evaluation
Clear procedures
Internal audits
CAPAs
SaMD
Vigilance reporting
Standards
Unannounced audits

Who is Karandeep Badwal?

Who is Monir El Azzouzi?

Links from the Video

Karandeep Badwal LinkedIn: https://www.linkedin.com/in/karandeepbadwal/
Youtube channel: https://www.youtube.com/c/QRAMedical
Podcast: https://open.spotify.com/show/32CvtseLj3KknqYDFdO7P3?si=4224628dd6d840e8

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post What are some Quality Common Mistakes? [Karandeep Badwal] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Medical Device News: June 2022 Regulatory Update

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 07 Jun 2022 02:30:00 +0000

Here is the news of the month. Enjoy.

NEWS

Swiss: MRA situation for IVDR; https://ec.europa.eu/health/document/download/8dd260fd-0b67-415b-bf1e-36bdf8681674_en?filename=md_eu-switzerland_mra_in-vitro-diagnostic.pdf
Swiss: new IvDV (Ordinance on in-vitro diagnostics): https://www.bag.admin.ch/bag/en/home/medizin-und-forschung/heilmittel/aktuelle-rechtsetzungsprojekte/revision-med-prod-verord-mepv.html
- Swiss Odiv: https://www.fedlex.admin.ch/eli/cc/2022/291/fr
Swiss: Performance studies of IVD: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/klinische-versuche/leistungsstudien.html
- https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw600_00_016e_mb_performance_studies_with_ivd.pdf.download.pdf/BW600_00_016e_MB_Information_performance_studies_IVD_KlinVMEP.pdf
EU: Team NB Survey: https://www.team-nb.org/wp-content/uploads/2022/05/Survey-2021-20220516.pdf
EU: Harmonized standard for IVDR: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32022D0729
EU: Harmonized standard for MDR: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32022D0757
Italy: Establishment of the National Surveillance Network: https://www.salute.gov.it/portale/news/p3_2_1_1_1.jsp?lingua=italiano&menu=notizie&p=dalministero&id=5894
Preparing for UKCA marking of Medical Device with Ronald Boumans: https://boumansconsulting.com/expert-center/tip-of-the-week/preparing-for-ukca-marking-of-medical-devices/
Green Belt Certification June 2022: https://school.easymedicaldevice.com/course/gb19/

NOTIFIED BODY

3EC International – IVDR 2017/746 – https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=317359&version_no=3
TÜV Nord – EU MDR 2017/745: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=317538&version_no=8
Berlin Cert – EU MDR https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.nb&body_type=NB&refe_cd=EPOS_43955
Overview NB each stage: https://ec.europa.eu/health/system/files/2022-05/notifiedbodies_overview_en.pdf

GUIDANCE

MDCG 2022-6 Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR: https://ec.europa.eu/health/document/download/14c2d8dd-8489-4db5-b035-1c174f17fb54_en?filename=mdcg_2022-6.pdf
MDCG 2022-7 Q&A UDI System: https://ec.europa.eu/health/document/download/b5429d14-25a9-4cfc-b059-355388f03e05_en?filename=mdcg_2022-7_en.pdf
MDCG 2022-8 IVD Legacy devices: https://ec.europa.eu/health/document/download/76f9983e-164c-45f1-b2b9-c9e5050cefe9_en?filename=mdcg_2022-8_en.pdf
MDCG 2022-9 Summary of safety and performance template: https://ec.europa.eu/health/document/download/b7cf356f-733f-4dce-9800-0933ff73622a_en?filename=mdcg_2022-9_en.pdf
MDCG 2022-10 Q&A interface 536/2014 on clinical trials for medicinal products for human use and IVDR: https://ec.europa.eu/health/document/download/59abcc81-fd32-4546-a340-24c8fad4e2ac_en?filename=mdcg_2022-10_en.pdf

PODCAST

Episode 179 – How to certify your Software as a Medical Device? With Vivek Thakkar: https://podcast.easymedicaldevice.com/179/
Episode 180 – What happens after the IVDR Date of Application with Colm O’Rourke: https://podcast.easymedicaldevice.com/180/
Episode 181 – What to learn about the EU Medical Device Situation? https://podcast.easymedicaldevice.com/181/
Episode 182– Let’s introduce our eQMS Smarteye with Anindya Mookerjea: https://podcast.easymedicaldevice.com/182/

The post Medical Device News: June 2022 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Let’s introduce you to our eQMS SmartEye with Anindya Mookerjea

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 31 May 2022 00:43:00 +0000

Big news, with my partners we have developed an eQMS called SmartEye!!! and we wanted to share with you why an eQMS is needed. For that, I have invited Anindya Mookerjea the CEO of SCube Technologies. We will talk about eQMS solutions and how the idea of SmartEye came. I was part of the development of certain modules and this is really satisfying to see that auditors or customers like them. Don’t forget to ask for a demo.

Who is Anindya Mookerjea?

Who is Monir El Azzouzi?

Links from the Video

Anindya Mookerjea Linkedin Profile: https://www.linkedin.com/in/anindya-mookerjea-6b5367209/
SCube Technologies website: https://scube-technologies.com/
SCube Technologies Linkedin Page: https://www.linkedin.com/company/scube-technologies/
Twitter account: https://twitter.com/scubetechno
Facebook account: https://www.facebook.com/i.scubetechnologies
Article Medical Device development: https://easymedicaldevice.com/medical-device-development/

The post Let’s introduce you to our eQMS SmartEye with Anindya Mookerjea appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

What to learn about the EU Medical Device situation? [Erik Vollebregt]

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 24 May 2022 00:45:00 +0000

The Medtech Forum occurred this year in Barcelona between May 3-5, 2022 During this conference, we recorded a podcast episode with Erik Vollebregt to summarize the discussions that happened. The topics that we will cover are:

Health Technology Assessment (HTA)
Digitalization for Medical Devices post-Covid
EU Commission not providing all the answers
Centralization for Medical Devices like FDA or EMA
Extension of EU MDR
Legacy devices versus New devices
New technologies pathway
EU Market versus US Market

Who is Erik Vollebregt?

Who is Monir El Azzouzi?

Links from the Video

Medtech Europe: https://www.medtecheurope.org/
Erik Vollebregt profile: https://www.linkedin.com/in/erikvollebregt/
Axon lawyers: https://www.axonlawyers.com/
HTA EU Commission: https://ec.europa.eu/health/health-technology-assessment/overview_en
Podcast episode 173 – EU MDR extension: https://podcast.easymedicaldevice.com/173/

The post What to learn about the EU Medical Device situation? [Erik Vollebregt] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

What happens after the IVDR Date of Application with Colm O’Rourke

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 17 May 2022 00:00:00 +0000

The IVDR 2017/746 will become live on May 26th, 2022 and this will be the big day for a lot of IVD companies.

To talk about the situation under IVDR, I have invited Colm O’Rourke from Trinzo to help us. Colm is sharing with us the situation for manufacturers. Also about Notified Bodies.

Who is Colm O’Rourke?

Colm O’Rourke is a regulatory and quality consultant with 10 years’ experience working in the medical device industry, including notified body, diagnostics manufacturer, and clinical laboratory experience. Colm works with manufacturers to achieve compliance through strategic planning, supporting the development of compliant technical and quality documentation, and assisting with regulatory submissions. Colm also delivers training on a number of topics including EU MDR and IVDR. Colm is a graduate of UCC, Ireland with a BSc in Biomedical Science, and NUI Galway, Ireland with a Dip. in Medical Device Science

Who is Monir El Azzouzi?

How to certify your Software as a Medical Device? (SaMD)

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 10 May 2022 00:00:00 +0000

Do you have a Software as a Medical Device or maybe you plan to have one? Then listen to this episode with Vivek Thakkar which will provide you some insight on what is SaMD and how to get Certified. If you need more details, please contact us so we can help you.

Who is Vivek Thakkar?

Regulatory affairs professional with a Master’s degree and 12 years of experience with Class II and Class III medical devices. Currently supporting regulatory activities for Artificial Intelligence and Machine Learning (AI/ML) in Software as a Medical Device (SaMD). Proven success in building and executing global regulatory strategies for interventional cardiovascular products. Skilled at hiring, training, and inspiring regulatory experts for medical device submissions. Passion for simplifying

Who is Monir El Azzouzi?

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post How to certify your Software as a Medical Device? (SaMD) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Medical Device News: May 2022 Regulatory Update

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 03 May 2022 00:50:00 +0000

Below are all the topics we will discuss during this episode. Don’t miss the latest updates.

EUDAMED
- EUDAMED & Certificate: https://ec.europa.eu/health/medical-devices-eudamed/notified-bodies-and-certificates-module_en
- EUDAMED Notified Body User guide: https://ec.europa.eu/health/document/download/8b6132fd-75ed-4e8b-8be5-920725037221_en?filename=md_eudamed-nb-user-guide_en_0.pdf
- EUDAMED Economic Operator User Guide: https://webgate.ec.europa.eu/eudamed-static/documents/assets/guides/user_guide_eo_en.pdf
Delegated acts: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=COM:2022:182:FIN
TURKEY: Reminder custom agreement: https://ec.europa.eu/health/latest-updates/notice-stakeholders-eu-turkey-customs-union-agreement-field-medical-devices-2022-04-13_en
Spain: CCPS registration of IVD until EUDAMED is fully available: https://www.aemps.gob.es/informa/notasinformativas/productossanitarios/2022-ps/informacion-sobre-la-comunicacion-de-productos-sanitarios-de-diagnostico-in-vitro-en-ccps/

USA

MDSAP Audit Approach: https://www.fda.gov/media/157861/download
FDA: Refuse to accept Policy for 510k: https://www.fda.gov/media/83888/download
FDA Medsun Newsletter: https://www.fda.gov/media/157448/download

MEA

Ethiopia: Labelling requirements: http://www.fmhaca.gov.et/wp-content/uploads/2022/04/Guidelines-for-Medical-device-Labeling.pdf

ASIA

Malaysia: Labelling requirements: https://www.mda.gov.my/documents/draft-guidance-documents/1969-attachment-1-public-comment-mda-gd0026-requirement-on-labelling-of-md/file.html

EVENT

Medtech Forum: https://www.themedtechforum.eu/
SFDA: Webinar Clinical Evaluation and PMCF: https://www.sfda.gov.sa/en/workshop/86686

GUIDANCES

MDCG Subgroup development and deliverables – https://ec.europa.eu/health/system/files/2022-04/mdcg_ongoing_guidancedocs_en.pdf
MDCG 2022-5 Borderline: https://ec.europa.eu/health/document/download/b5a27717-229f-4d7a-97b1-e1c7d819e579_en?filename=mdcg_2022-5_en_0.pdf
WHO Guidance: PMS for MD and IVD. https://www.who.int/publications/i/item/9789240015319

NOTIFIED BODIES:

IVDR: 3EC international. https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=317359&version_no=3

Easy Medical Device Nostalgia:

Episode 175: How to prepare an audit with Front Room Back Room: https://podcast.easymedicaldevice.com/175/
Episode 176: How your PMCF is evaluated by a Notified Body with Matthias Fink from TÜV SÜD: https://podcast.easymedicaldevice.com/176/
Episode 177: Training process with Rod Beuzeval and Katie Cooney from Trinzo and Meddev Solutions: https://podcast.easymedicaldevice.com/177/

The post Medical Device News: May 2022 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Training Process – What are the mistakes to avoid? [ISO 13485]

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 26 Apr 2022 00:30:00 +0000

The training process can create a lot of non-conformances during audits and this is why we will try to explain to you how to avoid that. Rod and Katie from Trinzo will be helping us to create a compliant training process. We will talk about internal training and also training organized by external companies. We will discuss the way an auditor can find some of the issues. The effectiveness monitoring will also be important to cover. So don’t miss this episode of the podcast.

Who is Rod Beuzeval?

Rod is a regulatory expert with 24 years’ experience in regulated pharmaceutical and medical device companies and holds a RAPS RAC Global scope certification. Rod develops and routinely delivers training on EU MDR,EU IVDR, MDSAP, ISO 13485, risk management, clinical evaluation and provides consultancy on projects within this realm. Throughout Rods career, he has worked with many medical device and IVD companies, helping them to achieve and maintain compliance. With both industry and notified body experience Rod is able to understand what exactly is needed and how to implement it in an effective manner.

Who is Katie Cooney?

Katie is the Training Centre of Excellence Lead at Trinzo She has over 15 years of experience in a variety of training roles and has performed these roles across all levels of the business. Her experience has been gained within Multinational Manufacturing including Medical Device, Pharmaceuticals and Automotive.

Who is Monir El Azzouzi?

Links from the Video

Rod LinkedIn: https://www.linkedin.com/in/rod-beuzeval-rac-00452317/?originalSubdomain=uk
Katie Linkedin: https://www.linkedin.com/in/katie-cooney-08ab7061/?originalSubdomain=ie
Meddev Solutions Website: www.meddevsolutions.co.uk
Trinzo Website: www.trinzo.com

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Training Process – What are the mistakes to avoid? [ISO 13485] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

How your PMCF is evaluated by your Notified Body? [Matthias Fink]

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 19 Apr 2022 02:00:00 +0000

PMCF is something that was existing before with MDD 93/42/EC but this is more in focus now with the new EU MDR 2017/745. In this episode, I have invited Matthias Fink from TÜV SÜD to help us understand some of the mistakes we are making in the creation of our PMCF. He will tell us what to do and how to distinguish between the different PMCF types.

Who is Matthias Fink?

Board-certified orthopedic and trauma surgeon with 17 years of experience in orthopedic, trauma, and reconstructive surgery and extensive training in cardiovascular and thoracic surgery. Working for TÜV SÜD Product Service in Germany since 2016 as a Clinical Reviewer in the Clinical Centre of Excellence before joining TÜV SÜD America in 2017. Senior Clinical Expert Orthopedic Surgery for the Clinical Centre of Excellence and the Team Manager of the Clinical Focus Team North America. Presenter at national and international conferences and workshops on the clinical requirements and the implementation of the EU MDR.

Who is Monir El Azzouzi?

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post How your PMCF is evaluated by your Notified Body? [Matthias Fink] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

How to prepare an Audit with a Front Room & a Back Room?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 12 Apr 2022 01:00:00 +0000

When you get audited, the configuration Front Room Back Room can help you a lot. But how to prepare for it? How to communicate between them? What are the rules to use this system?

I will tell you everything in this Podcast and if you need help don’t hesitate to contact me.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs.

After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world.

He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses…

Links from the Video

How to perform an Internal Audit: https://podcast.easymedicaldevice.com/80/
How to prepare for a Medical Device Audit: https://easymedicaldevice.com/medical-device-audit/
MDSAP audit: https://easymedicaldevice.com/mdsap/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post How to prepare an Audit with a Front Room & a Back Room? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Medical Device News: April 2022 Update

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 05 Apr 2022 02:00:00 +0000

HOT TOPIC

Joint implementation and preparedness plan for Regulation 2017/746: https://lnkd.in/dasedpRA
MDCG 2019-9 Rev 1 – SSCP update https://ec.europa.eu/health/document/download/5f082b2f-8d51-495c-9ab9-985a9f39ece4_en?filename=md_mdcg_2019_9_sscp_en.pdf
EU Handover of Experts Panels to EMA: https://ec.europa.eu/health/latest-updates/handover-experts-panels-secretariat-2022-03-02_en
SNITEM and BVMED ask for 2 additional years for the MDR transition period: https://www.bvmed.de/de/bvmed/presse/pressemeldungen/bvmed-und-snitem-starten-deutsch-franzoesische-initiative-zur-mdr-wir-muessen-jetzt-handeln
Swissmedic: Database for registering Economic Operators and Medical Devices: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank.html
AEMPS. Prior operating license for medical devices: https://www.aemps.gob.es/informa/notasinformativas/productossanitarios/2022-ps/nueva-instruccion-de-la-aemps-sobre-el-procedimiento-de-licencia-previa-de-funcionamiento-de-instalaciones-de-productos-sanitarios/
US MEDSUN: https://www.fda.gov/media/156691/download
China: Guidelines for registration and review of Artificial Intelligence Medical Devices: https://www.cmde.org.cn/CL0112/25219.html
Egypt: Guideline for labeling data on medical supplies: https://edaegypt.gov.eg/media/q23cqi5w/minimum-label-req-english-version_nancy-fateen.pdf

Events

Team PRRC Webinar April 12th, Sanctions if non-compliance to the regulation? https://www.linkedin.com/posts/team-prrc_mdr-ivdr-prrc-activity-6914642561617833985-5Moe
Medtech Forum 3-5 May 2022: https://www.themedtechforum.eu/
Green Belt Certification program
- French April 18th until April 22nd: https://school.easymedicaldevice.com/course/gbfr3/
- English April 25th, until April 29th: https://school.easymedicaldevice.com/course/gb18/

Notified Bodies

SIQ Slovenia Institute of Quality and Metrology: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=316903&version_no=12

EMD

Episode 170 – Why do we need the Common Specification for Class D IVDR [Andreas Stange] https://podcast.easymedicaldevice.com/170/
Episode 171 – What lesson did we learn doing Clinical Evaluations? [Cesare Magri] https://podcast.easymedicaldevice.com/171/
Episode 172 – How to sell Medical Devices online in the EU and US? [Michael Wetherington] https://podcast.easymedicaldevice.com/172/
Episode 173 – What are the surprises during the MDR & IVDR transition [Erik Vollebregt] https://podcast.easymedicaldevice.com/173/

The post Medical Device News: April 2022 Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

What are the surprises during MDR & IVDR transition? [Erik Vollebregt]

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 29 Mar 2022 00:00:00 +0000

There was an announcement earlier about the transfer of the Expert Panel for EU MDR & IVDR to the European Medicine Agency. So Pharma will take care of this.

Is there a possibility that we are moving to a model similar to the FDA?

Then another important piece of information came from SNITEM & BVMed. Both are asking for an extension of the EU MDR transition from May 2024 to May 2026.

Why and would this be considered by the EU Commission?

Let’s ask our preferred lawyer Erik Vollebregt. And I am sure this will help you understand all concepts for EU MDR and IVDR

Who is Erik Vollebregt

Erik specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software, and protection of personal data. He is an expert in life sciences regulation at the EU and Dutch level, with a focus on contracts, regulatory litigation against competent authorities, and M&A. Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms. He actively contributes to law and policy development at the national and EU levels via membership of specialized committees at branch associations and the European Commission. Erik also works as an arbitrator in medical devices-related disputes and is regularly retained as an expert witness in foreign litigation. Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish. Chambers Europe 2017: Erik is known for his specialism in regulatory work, which covers medical technology, devices, and products as well as biotechnology. Clients confirm his strong capabilities, with one saying “he stands out to me. Whenever I work with lawyers he has been the best, with a solid scientific background. He has the perfect combination of skills and experience.”

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses…

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post What are the surprises during MDR & IVDR transition? [Erik Vollebregt] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

How to sell Medical Devices online in the EU and US?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 22 Mar 2022 00:00:00 +0000

Since the implementation of EU MDR, there was a new phenomenon about Medical Device online sales. Online sales see their submissions to platforms like amazon rejected as they do have not all the documentation needed. This is also the same in the US market and it will become the same with EU IVDR when the date of implementation will start. So how do get in compliance? I have interviewed Michael Wetherington who will provide us with some hints on what should be done. If you need any support, don’t hesitate to contact me. I will then forward your request.

Who is Michael Wetherington?

Michael Wetherington is the Founder of MedicalRegs.com. MedicalRegs.com helps MedTech startups design devices with the applicable requirements in mind. They go further by providing regulatory services for the EU, US, Canada, and ASEAN markets. His background encompasses medical device R&D, accredited testing lab, and Notified Body experience. He is also a mentor at Elemed’s Mentoring Academy. And, when time permits, he likes to sing, play the drums, and the guitar.

Who is Monir El Azzouzi?

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post How to sell Medical Devices online in the EU and US? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

What lesson did we learn doing Clinical Evaluations? [Cesare Magri]

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 15 Mar 2022 00:43:00 +0000

Since MDR is live we get from surprises to surprises. And we wanted in this episode to share with you some lessons learned regarding Clinical Evaluation. You maybe noticed that between MDD and MDR the audit style for CER is different. Even if the requirements are mostly the same. So today we’ll try to guide you to be on the safe side with Cesare Magri from Be-on-Clinical.

Who is Cesare Magri?

Cesare has a mixed Background: Physics and Neuroscience, PhD in Informatics. He worked as a biostatistician at Max Planck in Tübingen and started working with medical devices and clinical evaluations in 2013. Recently he founded be-on-Clinical together with Stefan Bolleininger in 2020.

Who is Monir El Azzouzi?

Links from the Video

Cesare Magri Linkedin: https://www.linkedin.com/in/cesare-magri-92465345/
Be-on-Quality: https://www.be-on-quality.com/en/about-en/
Clinical Evaluation Template Pack: https://school.easymedicaldevice.com/product/clinical_pack/
Podcast Episode – Create Intended Purpose: https://podcast.easymedicaldevice.com/65/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post What lesson did we learn doing Clinical Evaluations? [Cesare Magri] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Why do we need the Common Specification for Class D IVDR?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 08 Mar 2022 00:00:00 +0000

For IVDR products, there is more and more information that is coming.

So we make a small summary with Andreas Stange from TÜV SÜD and then we will discuss specifically the Draft Common Specification for certain Class D devices.

Andreas will explain to you why we need these common specifications and if this is mandatory. He will also explain the problem that comes now when the transition date for certain devices were extended.

Andreas will also invite you to join TÜV SÜD if you are interested to be part of this Notified Body as an auditor. Multiple places in the world are looking for you.

I hope this will be informative to you.

Who is Andreas Stange?

Dr. Stange joined TÜV SÜD in 2001 as a medical device expert and had various positions since then in the group. Before taking the current position in March 2017, he served as President & CEO of TÜV SÜD in Japan for eight years.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs.

He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses…

Medical Device News – March 2022 Regulatory Update

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 01 Mar 2022 01:00:00 +0000

HOT TOPICS

IVDR
- Common Specification certain Class D IVD – https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13304-In-vitro-diagnostic-medical-devices-common-specifications_en
- Joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) – https://ec.europa.eu/health/document/download/558ede8b-ff9a-4a8f-bb9d-d61e4a515b6a_en
- EXPERT PANEL IVD:
  - https://ec.europa.eu/health/system/files/2022-02/pecp-ivd-2021-0000012-view_en.pdf

Spain – Registration of those responsible for placing medical devices on the market – https://www.aemps.gob.es/informa/notasinformativas/productossanitarios/2022-ps/la-aemps-pone-en-marcha-una-nueva-rps-para-el-registro-de-responsables-de-la-puesta-en-el-mercado-de-productos-sanitarios/

UK to pilot world-leading approach to improve ethical adoption of AI in healthcare – https://www.gov.uk/government/news/uk-to-pilot-world-leading-approach-to-improve-ethical-adoption-of-ai-in-healthcare>

Ireland – Certificate of Free Sale – https://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/aut-g0026-guide-to-applications-for-certificates-of-free-sale-for-medical-devices-v10.pdf?sfvrsn=55

TRAINING

MDR Training: https://school.easymedicaldevice.com/emd-course/

WORLDWIDE

Saudi Arabia – Guidance on Innovation Medical Devices https://www.sfda.gov.sa/sites/default/files/2022-02/InnovativeMDSG002_0.pdf
Application form for issuance of Saudi Free Sale Certificate https://www.sfda.gov.sa/sites/default/files/2022-02/App-Form-Issuance-Saudi-Free-Sale-CertifA_0.docx

China – Guidance for compilation of Technical Requirement for MD Products – https://www.cmde.org.cn/CL0112/25070.html

GUIDANCES

MDCG 2022-4 – Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR – https://ec.europa.eu/health/document/download/e5714b2b-e98b-4fce-b5ff-d9141a8f30e1_en

MDCG 2022-3 – Verification of manufactured class D IVDs by Notified Bodies – https://ec.europa.eu/health/document/download/ebbc4f6a-4945-4d5d-9c22-9bc1aafc5532_en

Ireland – Medical Device Classification guidance – https://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/adv-g0004-guide-to-classification-of-a-medical-device-v3.pdf?sfvrsn=15

NOSTALGIA

Podcast Episode 166 – Why Design History File DHF is so important? With Alexandros Savvidis https://podcast.easymedicaldevice.com/166/
Podcast Episode 167 – How to be great at Management Reviews https://podcast.easymedicaldevice.com/167/
Podcast Episode 168 – Why would you need a Swiss Authorized Representative and Importer? https://podcast.easymedicaldevice.com/168/

The post Medical Device News – March 2022 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Why would you need a Swiss Authorised Representative and Importer?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 22 Feb 2022 01:00:00 +0000

Since May 26th, 2021 Switzerland is now considered a non-EU country for Medical Devices. So to sell your products in Switzerland you need a Swiss Authorized Representative and a Swiss Importer. In this episode of the podcast, I will explain to you the reason for all that and the role and responsibility for the Manufacturer who wanted to ship its products to Switzerland and one of the Swiss Importers and Authorised Representative. If you have any questions, reach out to me: info at easymedicaldevice.com

Who is Monir El Azzouzi?

How to be great at Management Reviews? [ISO 13485]

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 15 Feb 2022 00:30:00 +0000

When we talk about Management Review, this is not really obvious how this should be done. In this video, I will try to explain to you what is expected to be seen by an auditor when they ask you to show them your Management Review. I will explain: – What is a Management Review – What you should consider when building your Management Review – Which documents are needed – What are the inputs and outputs with examples. I hope this will be helpful for you.

Who is Monir El Azzouzi?

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post How to be great at Management Reviews? [ISO 13485] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Why Design History File (DHF) is so important? [Alexandros Savvidis]

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 08 Feb 2022 00:00:00 +0000

DHF or Design History File or DMR or DHR or … What does all this mean? We will focus on DHF but we’ll also provide an explanation of the other acronyms.

In this episode of the Podcast, Alexandros Savvidis will share with us his experience. He’ll provide some examples. So don’t hesitate to check this episode if you are willing to get more understanding and ask your questions in the comments.

Who is Alexandros Savvidis?

Alexandros Savvidis is a Senior Medical Device Specialist active more than 17 years in multiple areas including Regulatory Affairs, Quality Management, R&D, Sales, Technical Support & Analysis.

After his studies in Biomedical Engineering, he has worked in the medical devices as also the pharma packaging industry across Europe in Germany, Switzerland, Netherlands, UK, and Greece. He has organized and contributed as an RA Specialist to various successful international certifications of medical devices of all classes.

Alexandros has gained one overall experience and deep understanding through his various roles on the full norm compliant development and certification process, like many other aspects like GMP, quality, risk management, vigilance, or clinical evaluations.

He has worked on small, middle-size companies alone or a team member, or even on cross-functional teams of Life Science Giants. In the last years is his main focus is the implementation of MDR requirements and updates

Who is Monir El Azzouzi?

He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses…

Links from the Video

Alexandros Linkedin Profile: https://www.linkedin.com/in/alexandrossavvidis/
What is a DHF?: https://www.greenlight.guru/glossary/design-history-file

The post Why Design History File (DHF) is so important? [Alexandros Savvidis] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Medical Device News: February 2022 Regulatory Update

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 01 Feb 2022 00:00:00 +0000

The February 2022 Regulatory Update contains a lot of information that may help you to maintain your team up-to-date with the new requirements.

Agenda:

IVDR news on transition, Expert Panel and Finland reminder
Clinical Trial Regulation in EU and UK
Training EU MDR 2017/745
EUDAMED Certificate module
EU Reinforced role for EMA on medical device and medicinal product shortage
Harmonized Standards
Annex XVI Draft
Switzerland Good Reprocessing Practices
Re-registration within MHRA
Bahrain medical device that doesn’t need registration
Newsltetter: FDA Medsun and Japan PMDA
MDCG guideline
Notified Body situation
EMD Podcast

LINKS

IVDR

IVDR: (EU) 2022/112 : https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32022R0112&from=EN
Expert Panel: Performance Evaluation: https://ec.europa.eu/health/medical-devices-expert-panels/experts/list-views-provided-and-ongoing-consultations-under-pecp_en
Finland – FIMEA: At home-test Covid 19: https://www.fimea.fi/web/en/-/fimea-reminds-importers-and-distributors-of-covid-19-at-home-tests-of-the-special-requirements-related-to-the-tests

Clinical

Regulatory harmonization of clinical trials in the EU: Clinical Trials Regulation to enter into application and new Clinical Trials Information System to be launched https://www.ema.europa.eu/en/news/regulatory-harmonisation-clinical-trials-eu-clinical-trials-regulation-enter-application-new
UK: Consultation on proposals for legislative changes for clinical trials https://www.gov.uk/government/consultations/consultation-on-proposals-for-legislative-changes-for-clinical-trials

Training

Green Belt Certification Program Edition 16: February 21st to February 25th: https://school.easymedicaldevice.com/course/gb16/

Divers

EUDAMED Certificates module: https://ec.europa.eu/tools/eudamed/#/screen/certificates
- Podcast episode 111 with Leon Doorn: https://podcast.easymedicaldevice.com/111/
EU – REINFORCED ROLE FOR THE EUROPEAN MEDICINES AGENCY IN CRISIS PREPAREDNESS AND MANAGEMENT FOR MEDICINAL PRODUCTS AND MEDICAL DEVICES https://data.consilium.europa.eu/doc/document/PE-76-2021-REV-1/en/pdf
Harmonized Standards (New Webpage): https://ec.europa.eu/health/medical-devices-topics-interest/harmonised-standards_en
European Commission: Draft Common Spec Annex XVI Consultation page: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/11629-Products-with-an-aesthetic-or-non-medical-purpose-safety-requirements_en
Switzerland: Good Reprocessing Practices: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/reprocessing—maintenance/reprocessing.html
UK Responsible Person: Re-registration of MHRA accounts: https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk
Bahrain: Which Medical Device should not be registered: https://www.nhra.bh/Media/Announcement/MediaHandler/ImageHandler/documents/Announcements/Announcement2022_Circular%20No.%20(01)%202022_T0%20All%20Medical%20Devices%20Companies%20and%20Healthcare%20Facilities_Cases%20that%20Will%20Not%20be%20Included%20in%20Medical%20Devices%20Regulation_20220119.pdf

Newsletter

USA: Medsun Newsletter January 2022: https://www.fda.gov/media/155206/download
PMDA Japan: https://www.pmda.go.jp/files/000244668.pdf

Guidance:

MDCG 2022-1: Notice to 3rd country manufacturers of SARS-CoV-2 in vitro diagnostic medical devices https://ec.europa.eu/health/document/download/cd617093-f2bd-4a99-9058-9805ce4d0db3_en
MDCG 2022-2 General principle of Clinical Evidence for IVDs: https://ec.europa.eu/health/latest-updates/mdcg-2022-2-guidance-general-principles-clinical-evidence-vitro-diagnostic-medical-devices-ivds-2022-01-27_en

NB:

ITALCERT SRL EU MDR: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=315596&version_no=10

PODCAST:

Episode 162: How to accelerate your laboratory test results? https://podcast.easymedicaldevice.com/162/
Episode 163: How to interview a QA RA Candidate? https://podcast.easymedicaldevice.com/163/
Episode 164: MDCG 2021-27: https://podcast.easymedicaldevice.com/164/

The post Medical Device News: February 2022 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

MDCG 2021-27 Placing on the market & Re-labelling with Erik Vollebregt

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 25 Jan 2022 00:00:00 +0000

The MDCG 2021-27 on Articles 13 and 14 of the EU MDR 2017/745 is creating some problems because of the vocabulary used. Erik Vollebregt, a lawyer at Axon Lawyers is helping us to understand the problem some vocabulary used can generate. In this case, we will focus on 2 of the elements: – Placing on the market – Importer relabelling. Don’t hesitate to look at the show notes for more details.

Who is Erik Vollebregt?

Erik specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software, and protection of personal data. He is an expert in life sciences regulation at the EU and Dutch level, with a focus on contracts, regulatory litigation against competent authorities, and M&A. Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms. He actively contributes to law and policy development at the national and EU levels via membership of specialized committees at branch associations and the European Commission. Erik also works as an arbitrator in medical devices-related disputes and is regularly retained as an expert witness in foreign litigation. Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish. Chambers Europe 2017: Erik is known for his specialism in regulatory work, which covers medical technology, devices, and products as well as biotechnology. Clients confirm his strong capabilities, with one saying “he stands out to me. Whenever I work with lawyers he has been the best, with a solid scientific background. He has the perfect combination of skills and experience.”

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses…

Links from the Video

Erik Vollebregt Linkedin Profile: https://www.linkedin.com/in/erikvollebregt/
Axon Lawyers: https://www.axonlawyers.com/
Medical device legal blog: https://medicaldeviceslegal.com/2021/12/28/mdcg-2021-27-qa-on-importers-and-distributors-sort-of-box-of-chocolates/
MDCG 2021-27: https://ec.europa.eu/health/system/files/2021-12/mdcg_2021-27_en.pdf

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post MDCG 2021-27 Placing on the market & Re-labelling with Erik Vollebregt appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

How to interview your QA RA Candidates? [Mitch Robbins]

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 18 Jan 2022 00:00:00 +0000

If you are a Quality or Regulatory affairs hiring manager then you may need to understand how to interview your candidates. I have asked Mitch Robbins from the Anthony Michael Group which is a Recruiting Agency to help us with some techniques.

Mitch Robbins will explain to you how to prepare prior to the interview, what kind of information you need to identify during the interview and what is the activities after. If you follow that, you will have a high chance to recruit the right candidate for your organization. I hope this will help you.

Who is Mitch Robbins?

Who is Monir El Azzouzi?

Links from the Video

Mitch´s Linkedin Profile: https://www.linkedin.com/in/mitchrobbins/
The Anthony Michael Group: https://theanthonymichaelgroup.com
Episode: Be the best candidate ever: https://podcast.easymedicaldevice.com/38/

The post How to interview your QA RA Candidates? [Mitch Robbins] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

How to accelerate your Laboratory Test Results? [Christoph Lindner]

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 11 Jan 2022 02:00:00 +0000

I am sure you were in this situation where you had to execute some Laboratory Tests for the compliance of your medical device and thought that you just need to contact them so they can execute the test. But the reality is different. They may ask you a lot of questions that you don’t understand. So on this podcast episode, we help you define the best process for you to approach a Laboratory with the support of Christoph Lindner from TÜV SÜD. He will share with us his knowledge and tips for you to accelerate your lab test results.

Who is Christoph Lindner?

Christoph Lindner is the Team Leader for Medical Device testing at TÜV SÜD. He has a Ph.D. in Organic Chemistry. His career in the industry was on ophthalmology products and also on Laboratory testing. Before being in charge of the Medical Device testing at TÜV SÜD he first became a Notified Body Auditor which helps him to have a clear understanding of the regulatory requirements.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He is now in charge of the consulting firm Easy Medical Device in Switzerland, Belgium, and the UK and developed many ways to deliver knowledge through Videos, podcasts, online courses… He offers also the service of an Authorized Representative for his customers.

Medical Device News – January 2022 [Happy New Year]

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 04 Jan 2022 03:00:00 +0000

Happy New Year 2022. All my best wishes for this year. For all the updates. check the links below.

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Medical Device News – January 2022 [Happy New Year] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

What happened in 2021? Summary for the Medical Device Industry

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 28 Dec 2021 02:00:00 +0000

The year 2021 was really full of updates for the Medical Device Industry. I can understand that it goes so fast you cannot follow. So I tried to summarize the year 2021 and also tell you some objectives that we are planning for 2022. So I hope this will give you some important information.

Who is Monir El Azzouzi?

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post What happened in 2021? Summary for the Medical Device Industry appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

The Step-by-Step recipe to get MDR & IVDR Certified

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 21 Dec 2021 02:00:00 +0000

For this episode, I wanted to show you how it is possible to plan your MDR & IVDR certification. This is a question that people ask me when they reach out. “What should I do to get ready for MDR or IVDR certification?”

So here we will talk about:

Quality Management System
Technical Documentation
Clinical Evaluation
Audit readiness
Audit completion
Certification

I hope this will help you in your process. In case you need support don’t hesitate to reach out. My team and I are ready to help you.

Who is Monir El Azzouzi?

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post The Step-by-Step recipe to get MDR & IVDR Certified appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Which devices cannot be Custom-made? [Erik Vollebregt]

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 14 Dec 2021 00:00:00 +0000

The EU MDR is changing a lot of things for medical devices, and even on Custom-made. The definition changes and has a huge impact on already marketed products. The manufacturers have to assess their portfolio to define again if their products are custom-made or not. In this episode, Erik Vollebregt will try to explain to you the rules you’ll need to follow.

Who is Erik Vollebregt?

Erik specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software, and protection of personal data. He is an expert in life sciences regulation at the EU and Dutch level, with a focus on contracts, regulatory litigation against competent authorities, and M&A. Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms. He actively contributes to law and policy development at the national and EU levels via membership of specialized committees at branch associations and the European Commission. Erik also works as an arbitrator in medical devices-related disputes and is regularly retained as an expert witness in foreign litigation. Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish. Chambers Europe 2017: Erik is known for his specialism in regulatory work, which covers medical technology, devices, and products as well as for biotechnology. Clients confirm his strong capabilities, with one saying “he stands out to me. Whenever I work with lawyers he has been the best, with a solid scientific background. He has the perfect combination of skills and experience.”

Who is Monir El Azzouzi?

Medical Device News: December 2021 Regulatory Update

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 07 Dec 2021 02:00:00 +0000

EUDAMED
- Commission implementing regulation 2021/2078: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32021R2078
- EUDAMED webpage: https://ec.europa.eu/health/md_eudamed/udi_devices_registration_en
- EUDAMED Playground: https://webgate.training.ec.europa.eu/eudamed-play/landing-page#/
- UDI/Devices guidance: https://ec.europa.eu/health/sites/default/files/md_eudamed/docs/md_eudamed_udi-devices-user-guide_en.pdf
- Infographic EUDAMED: https://ec.europa.eu/health/sites/default/files/md_eudamed/docs/md_eudamed-udi-concept_en.pdf
- Categorization of devices: https://ec.europa.eu/health/sites/default/files/md_eudamed/docs/md_eudamed-devices_en.pdf
- Registration process: https://ec.europa.eu/health/sites/default/files/md_eudamed/docs/md_eudamed-udi-registration-process_en.pdf
IVDR expert panel
- View in the context of the Performance Evaluation Consultation Procedure (PECP): https://ec.europa.eu/health/sites/default/files/md_expertpanels/docs/pecp-ivd-2021-000002-view_en.pdf
- Following MDCG 2021-22 https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-22_en.pdf
EU Reference laboratories (EURL)
- Feedback on Draft implementing regulation open until December 17th, 2021: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13272-EURL-fees_en
Germany: Contact Persons for Medical Devices https://www.bfarm.de/EN/Medical-devices/Contact-persons/_artikel.html?nn=968830
Ireland – HPRA: In-house Manufacturing of in vitro diagnostic medical devices – Survey
- Due December 17th, 2021 http://www.hpra.ie/homepage/medical-devices/news-events/item?t=/in-house-manufacturing-of-in-vitro-diagnostic-medical-devices-stakeholder-survey&id=07891026-9782-6eee-9b55-ff00008c97d0
Ireland – HPRA: Update on the creation of Free Sale Certificate in Ireland: http://www.hpra.ie/homepage/medical-devices/news-events/item?t=/applying-for-a-certificate-of-free-sale-updated-information&id=d4731026-9782-6eee-9b55-ff00008c97d0
Annex XVI products – Finland – FIMEA
- https://www.fimea.fi/web/en/-/supervision-of-devices-referred-to-in-annex-xvi-of-the-medical-device-regulation-to-begin-in-autumn-2022
CHRISTMAS BREAK
- MHRA Christmas period: Clinical Investigation: https://www.gov.uk/guidance/notify-mhra-about-a-clinical-investigation-for-a-medical-device
- Belgium – FAMHP – Christmas period https://www.famhp.be/en/news/deadlines_for_the_submission_of_dossiers_during_end_of_year_period
Switzerland: Registration of Economic Operators: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/market-access/registriernummer-chrn.html
- CH-RN Database: https://opendata.swiss/en/dataset/mep401-chnr-actors
- How to obtain the CHRN: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw630_11_001defi_fo-registrierungsantrag-einmalige-idnr-art55-mepv.pdf.download.pdf/BW630_11_001defi_FO_Antrag_Registrierung_CHRN.pdf
Switzerland – Procurement: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/reprocessing—maintenance/beschaffung.html
UK MHRA: Review launched into the health impact of potential bias in medical devices : https://www.gov.uk/government/news/review-launched-into-the-health-impact-of-potential-bias-in-medical-devices
WORLD
- USA: Final rule for Medical Device De Novo Classification Process
  - https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-final-rule-medical-device-de-novo-classification-process
  - Podcast episode 43 – How to register a Medical Device with FDA? (510k, PMA, DeNovo) How to register a Medical Device with FDA? (510k, PMA, de Novo…)
- USA: Draft Guidance 510K Device Software function SaMD
  - Webinar Dec 16th, 2021 – Draft Guidance: Content of Premarket Submission for Device Software functions: https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-draft-guidance-content-premarket-submissions-device-software-functions-12162021-12162021
  - Draft guidance: https://www.fda.gov/media/153781/download
- USA: Voluntary eSTAR Program: https://www.fda.gov/medical-devices/premarket-notification-510k/voluntary-estar-program
  - Non-in vitro diagnostic eStar Version 1: https://www.fda.gov/media/154429/download
  - In Vitro Diagnostic eStar Version 1: https://www.fda.gov/media/154430/download
- Saudi Arabia: Borderline products https://www.sfda.gov.sa/sites/default/files/2021-11/GuidanceBorderlineProductsClassificationE.pdf
Notified Body
EMD
- Podcast
  - Episode 153 – How to improve your QA RA Communication with Lesley Worthington: https://podcast.easymedicaldevice.com/153/
  - Episode 154 – Is it possible to Private Label a Medical Device under MDR and IVDR with Erik Vollebregt: https://podcast.easymedicaldevice.com/154/
  - Episode 155 – How to approach your Notified Bodies? With Dr Royth von Hahn https://podcast.easymedicaldevice.com/155/
  - Episode 156 – Unleashing “MDR Classification surprises with Franck Matzek https://podcast.easymedicaldevice.com/156/
- LinkedIn Live
  - Talk Cybersecurity during MDR audit with Stefan Bolleininger: https://www.youtube.com/watch?v=IK0DiXnISKE&t=4s
  - IVDR 2017/746 – in-house devices: https://www.youtube.com/watch?v=AbwaA7DpbYI

The post Medical Device News: December 2021 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Let’s unleash “MDR Classification surprises” [MDR 2017/745]

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 30 Nov 2021 02:00:00 +0000

Recently the MDCG guidance for Medical Device classification was published. And I wanted to have someone to help us decode it. Frank Matzek accepted to share his knowledge as he worked on the consultation of this guidance and he can tell us if there are some specific elements to look at. The discussion of today will be mainly on the changes related to the new EU MDR 2017/745. We will also discuss a bit of the EU MDD 93/42/EC

Who is Frank Matzek?

Frank Matzek is a Medical Device expert with 40 years of experience. He worked within a Test and Certification body called BerlinCert where he was the technical expert. Then he entered BIOTRONIK as Regulatory Affairs Manager and didn’t leave it until now. He is now the Vice-President of Regulatory & Government affairs. Additionally, Frank is also part of the BVMed as a member and vice-chair of the Regulatory Affairs Committee (AKRA) and lastly member of the MedTech Europe.

Who is Monir El Azzouzi?

Links from the Video

Frank Matzek Profile: https://www.linkedin.com/in/frank-matzek-a43617/
Biotronik website: https://www.biotronik.com/?campaign=linkedinus
MDCG 2021-24: https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-24_en.pdf
MEDDEV classification guidance: https://ec.europa.eu/docsroom/documents/10337/attachments/1/translations/en/renditions/native

The post Let’s unleash “MDR Classification surprises” [MDR 2017/745] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

How to approach your Notified Bodies? [Dr. Royth von Hahn – TÜV SÜD]

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 23 Nov 2021 02:00:00 +0000

One of the most stressful situations in the medical device business is the selection and the work with Notified Bodies. Why?

Because there are less than what we need and because it is difficult to budget their service. So I have invited the Head of the TÜV SÜD Healthcare Business Unit to tell us more about the Notified Body Situation.

We will discuss:

The increase of Notified Body Scope
The Covid Restrictions
The strategy US – EU for market access
The cost of Notified Bodies
When to contact a Notified Body?
Annex XVI products
The IVDR proposal to delay some of the product classes
Sustainability

So if you need to understand better the situation of Notified Bodies and how to work with them then this is the Podcast to listen to.

Who is Dr Royth von Hahn?

Dr. Royth von Hahn has taken over as the new Business Unit Manager Medical & Health Services (MHS) at TÜV SÜD Product Service. Operating from San Diego (USA), he will be responsible for a network of around 600 experts and a portfolio of lifecycle services for medical devices, from product design to risk management and approval. Dr von Hahn succeeds Dr. Peter Havel, who transfers to TÜV SÜD Product Service GmbH in Munich as CEO.

Who is Monir El Azzouzi?

Is it possible to Private Label a Medical Device under MDR & IVDR?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 16 Nov 2021 02:18:00 +0000

If you are a company buying products from a supplier and then putting your brand on it to sell it in Europe, then you are an Own Brand Labeller or Private Labeller, or Virtual Manufacturer.

In this episode, we will discuss this business model and what are the options for you as this is not really possible under EU MDR 2017/745 or EU IVDR 2017/746. Erik Vollebregt will provide some information on some cases where OBL is involved and also explain your choices, like importer or distributor…

Who is Erik Vollebregt?

Erik also works as an arbitrator in medical devices-related disputes and is regularly retained as an expert witness in foreign litigation. Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish.

Chambers Europe 2017: Erik is known for his specialism in regulatory work, which covers medical technology, devices, and products as well as for biotechnology. Clients confirm his strong capabilities, with one saying “he stands out to me. Whenever I work with lawyers he has been the best, with a solid scientific background. He has the perfect combination of skills and experience.”

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with a big Healthcare company, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand the Medical Device Regulations worldwide.

He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses…

Link

Erik Vollebregt Linkedin Profile: https://www.linkedin.com/in/erikvollebregt/
Axon Lawyers: https://www.axonlawyers.com/
Erik’s blog: https://medicaldevicelegals.com

The post Is it possible to Private Label a Medical Device under MDR & IVDR? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

How to improve your QA RA Communication with Lesley Worthington?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 09 Nov 2021 02:00:00 +0000

We always think that what is most important in QA RA is to know the regulation. NO!.

What is most important is to be able to transmit this knowledge to the other colleagues within your company.

But to do that you need to understand certain parameters and this is what we will discuss today with Lesley Worthington. This podcast will help you improve your communication skill by understanding the situation.

Who is Lesley Worthington?

Lesley is a Toronto-based Communication Skills and Writing Coach for professionals working in medical devices, pharma, and biotechnology.

She combines her passion for empowering others, her passion for words, and her two decades of experience in a Quality Assurance/Regulatory Affairs role to help others become more impactful in their careers.

She works with non-native English speakers looking for guidance and improved confidence in navigating an English-speaking business world. And she works with native and non-native English speakers to adjust their writing for the business world and shows them the power of plain language in connecting with others, reducing mistakes and misunderstandings, saving time, spreading ideas, and getting things done.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs.

He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses…

Links from the Video

Lesley Worthington Linkedin: https://www.linkedin.com/in/lesleyworthington/
QA RA Mindset with Michelle Lott: https://podcast.easymedicaldevice.com/114/

The post How to improve your QA RA Communication with Lesley Worthington? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Medical Device News – November 2021 latest update

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 02 Nov 2021 03:00:00 +0000

In this episode of the Podcast we will review:

IVDR proposal to delay transition periods
Cobalt on medical devices as CMR
Artificial Intelligence
MDCG guidance
Notified Body overview

Check links below

Who is Monir El Azzouzi?

Links

Implementing Rolling Plan https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_rolling-plan_en.pdf
IVDR proposal for new transition period: https://ec.europa.eu/commission/presscorner/detail/en/ip_21_5209 https://ec.europa.eu/commission/presscorner/detail/en/qanda_21_5210
- PDF Q&A: https://ec.europa.eu/commission/presscorner/api/files/document/print/en/qanda_21_5210/QANDA_21_5210_EN.pdf
- Draft Regulation: https://ec.europa.eu/health/sites/default/files/md_newregulations/docs/md_2017-746-regulation_2021-amendment_en.pdf
ANSM: From October 1st 2021 Cobalt as CMR following 2020/2017: https://ansm.sante.fr/actualites/evolution-reglementaire-impactant-les-dispositifs-medicaux-qui-contiennent-du-cobalt
Listed on CLP 1272/2008 Annex VI: https://eur-lex.europa.eu/legal-content/FR/TXT/?uri=celex%3A32008R1272
Guideline to justify CMR is called SCHEER which provides elements to justify with benefit/risk analysis. https://ec.europa.eu/health/sites/default/files/scientific_committees/scheer/docs/scheer_o_015.pdf
TEAM NB – Proposal for Notified Body Opinion Template for Article 117: https://www.team-nb.org/wp-content/uploads/2021/10/Team-NB-PositionPaper-Article117-NB-Opinion-Template-V1.pdf
TEAM NB – European Artificial Intelligence: https://www.team-nb.org/wp-content/uploads/2021/10/Team-NB-PositionPaper-Artificial-Intelligence.pdf
UK MHRA – US, Canada and UK identified 10 guiding principles for AI softwares https://www.gov.uk/government/publications/good-machine-learning-practice-for-medical-device-development-guiding-principles
UK MHRA – Consultation on Futur Regulation https://www.gov.uk/government/consultations/consultation-on-the-future-regulation-of-medical-devices-in-the-united-kingdom
UK MHRA – Infusion Pump T34 from BD https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1026856/T34_syringe_pump_guidance_for_gov-uk.pdf
MHRA Board meeting held in public – eventbrite: https://www.eventbrite.co.uk/e/mhra-board-meeting-held-in-public-tickets-195778337277
Turkey
- EU MDR 2017/745 – May 2021 https://titck.gov.tr/storage/Archive/2021/announcement/Ek1TbbicihazGBOKbeyanmetni_83778294-b01e-47a2-b868-e33c1dd02bc3.pdf
- EU IVDR 2017/746 – Sept 2021 https://titck.gov.tr/storage/Archive/2021/announcement/Ek2InvitroGBOKbeyanmetni_1d33cd35-632a-4abb-87ea-803ef67f4977.pdf
Philippine – FDA Circular for retailers of Medical Devices – License to sell medical devices is needed https://www.fda.gov.ph/wp-content/uploads/2021/10/FDA-Circular-No.2021-021.pdf • Thailand FDA – HAS Singapore – Regulatory reliance program: https://bit.ly/3nN1PBo
Japan – PMDA update https://www.pmda.go.jp/files/000243366.pdf
- Online platform to learn the regulation in Japan: https://www.pmda.go.jp/english/int-activities/training-center/0005.html
- Other course: https://www.pmda.go.jp/english/int-activities/training-center/0006.html
EVENTS
- ACRAS – Nov 24th and 25th https://acras.me/
NOTIFIED BODIES
- Overview of Notified Body Situation https://ec.europa.eu/health/sites/default/files/md_newregulations/docs/notifiedbodies_overview_en.pdf
GUIDANCE
- MDCG 2021-24 – Classification https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-24_en.pdf
- MDCG 2021-25 Legacy devices https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2021_25_en.pdf
- MDCG 2021-26 Article 16 Importer Distr Q&A https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2021_26_en.pdf
PODCAST
- Episode 149 – EUDAMED Update with Richard Houlihan https://podcast.easymedicaldevice.com/149/
- Episode 150 – CMR substances with Ana Luiza Cassin Duz https://podcast.easymedicaldevice.com/150/
- Episode 151 – IVDR is not postponed with Erik Vollebregt https://podcast.easymedicaldevice.com/151/

The post Medical Device News – November 2021 latest update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

How does the EU Commission plan to save IVDR 2017/746?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 26 Oct 2021 01:20:00 +0000

A few weeks ago, we were surprised to hear that the EU Commission issued a proposal to delay some products from applying IVDR 2017/746 by my 26th, 2022.

So we decided to discuss this proposal with Erik Vollebregt and see how this should be interpreted as this is not a postponement that is proposed but more some phase application per product class.

Erik presented also during this session a diagram that he has made. I asked him to be able to provide that to you so check the links below to find it.

You can also read more of this proposal on Erik’s blog. The link is also below.

Who is Erik Vollebregt?

Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms. He actively contributes to law and policy development at the national and EU levels via membership of specialized committees at branch associations and the European Commission. Erik also works as an arbitrator in medical devices-related disputes and is regularly retained as an expert witness in foreign litigation. Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish.

Who is Monir El Azzouzi?

How to comply with MDR when products contain CMR Substances?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 19 Oct 2021 02:00:00 +0000

In this episode, we will discuss CMR which are some substances that can be dangerous for your health. They are classified by legislation and we will explain to you what you should do.

Ana Luiza Cassin Duz, Clinical Specialist will help us to define what are the MDR requirements and how you can follow the rules and be compliant. In a previous episode, Martin Witte from TÜV SÜD explained that one of the common issues discovered during an MDR audit is the fact that manufacturers were not looking at CMR substances on their products.

So I hope this episode will provide you with all the methods you have to follow to be EU MDR 2017/745 compliant.

Who is Ana Luiza Cassin Duz?

She holds a Bachelor’s Degree in Biological Sciences, a Master’s Degree in Cellular Biology, a Ph.D. in Biological Sciences, and an MBA in Quality Management.

She has worked for the past 10 years in the quality, regulatory and clinical evaluation of various types of medical devices, such as Biological Heart Valve, Endoprosthesis, Inorganic valved conduit, Annular Rings; as well as, Extracorporeal circulation machine, Defibrillator, Cardioverter, and Patient monitors; in addition to Intrastromal corneal ring, Intraocular lens, and Contact lenses.

Who is Monir El Azzouzi?

He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses…

EUDAMED Update: Should you register your medical devices now?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 12 Oct 2021 02:00:00 +0000

Recently EUDAMED made a major Update which was the release of the Device registration module. This is something that all Medical Device manufacturers need to listen to as this may impact their workload.

Richard Houlihan from Eudamed.com accepted to come and tell us more about this update and provide you also with some advice on how to manage it.

So we will talk:

EUDAMED progress
EUDAMED Device registration module
Should you register now or later
Should you do it manually or use a service provider

Richard Houlihan is also providing training to your team on how to implement EUDAMED so don’t miss it. The links are below.

Who is Richard Houlihan?

Richard Houlihan has been in IT-related businesses for 25+ years. He holds a BSc in Computing and an MBA in Information management. The varying IT roles have led to him living in several countries, working across 6 blue chips, 3 start-ups, and 3 different directorates within the European Commission.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, Online courses…

Medical Device News – October 2021 Regulatory Update

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 05 Oct 2021 02:30:00 +0000

Here are all the topics that we will cover during this regulatory update. Don’t forget to contact easy medical device if you need an EU-authorised representative, a Swiss representative or a UK-responsible person.

HOT TOPIC

Implementing Rolling Plan: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_rolling-plan_en.pdf
EUROPA IVDR expert panel: https://ec.europa.eu/health/md_expertpanels/overview_en
EUDAMED Device module https://ec.europa.eu/tools/eudamed/#/screen/home
Helsinki Procedure 2021: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_border-class_helsinki-proc-mdr-ivdr_en.pdf
Medtech Europe – Availability of IVD devices in May 2022 https://www.medtecheurope.org/resource-library/medtech-europe-survey-report-analysing-the-availability-of-in-vitro-diagnostic-medical-devices-ivds-in-may-2022-when-the-new-eu-ivd-regulation-applies/
IMDRF Artificial intelligence: http://www.imdrf.org/docs/imdrf/final/consultations/imdrf-cons-aimd-mlmd-ktd-wgpd-n67.pdf

EMD training

Green Belt Edition 14: https://school.easymedicaldevice.com/course/gb14/

SWISSMEDIC

Swissmedic Information session September 2nd, 2021 https://www.swissmedic.ch/swissmedic/en/home/services/veranstaltungen/info-medizinprodukte-regulierung.html
Swissmedic- Combination products: https://www.swissmedic.ch/swissmedic/en/home/news/mitteilungen/ch-bevollmaechtigter-kombiprodukte.html

MHRA

MHRA- Transforming the regulation of Software and artificial intelligence as Medical Devices https://www.gov.uk/government/news/transforming-the-regulation-of-software-and-artificial-intelligence-as-a-medical-device
Software and AI as Medical Device Change Programme https://www.gov.uk/government/publications/software-and-ai-as-a-medical-device-change-programme/software-and-ai-as-a-medical-device-change-programme
MHRA Consultation on the future Regulation of Medical Devices in the UK. https://www.gov.uk/government/consultations/consultation-on-the-future-regulation-of-medical-devices-in-the-united-kingdom?utm_medium=email&utm_campaign=govuk-notifications&utm_source=5b7f9b8d-f894-4288-bc55-148816deedd2&utm_content=daily
MHRA webinar – Consulting on Future of Medical Device Regulation for industry: https://www.eventbrite.co.uk/e/mhra-consultation-on-future-medical-devices-regulation-in-the-uk-industry-tickets-166144503683
MHRA registration renewal: https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market#review-registration

SPAIN

AEMPS – Carlos III Health Institute presents the National Registry of Circulatory and Respiratory Assistance Devices in Spain. https://www.aemps.gob.es/la-aemps/eventos/2021-eventos/presentacion-del-registro-renacer/
Change of labeling and IFU for Swiss Manufacturers https://www.aemps.gob.es/informa/notasinformativas/productossanitarios/2021-productossanitarios/informacion-sobre-productos-sanitarios-en-base-al-acuerdo-de-reconocimiento-mutuo-mra-ue-suiza/

FDA

USA Device Registration and Listing: https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing
List of who must register and pay: https://www.fda.gov/medical-devices/device-registration-and-listing/who-must-register-list-and-pay-fee
FDA – List of AI and Machine Learning ML devices: https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices

NOTIFIED Body

TÜV Rheinland Italia SRL: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=314154&version_no=8

GUIDANCES

Borderlines with Medical Devices https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1022543/Rev_Borderlines_with_medical_devices_and_other_products-_V1_4_80_.pdf
FDA Electronic submission template for Medical Device 510k: https://www.fda.gov/media/152429/download

EMD Nostalgia

Podcast Episode 144 https://podcast.easymedicaldevice.com/144/
Podcast Episode 145 https://podcast.easymedicaldevice.com/145/
Podcast Episode 146 https://podcast.easymedicaldevice.com/146/
Podcast Episode 147 https://podcast.easymedicaldevice.com/147/

The post Medical Device News – October 2021 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Why does an Importer/Distributor need to appoint a Notified Body?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 28 Sep 2021 00:00:00 +0000

Recently MDCG issued the guidance on Article 16 of the EU MDR & IVDR.

This provided some surprises. So now in certain circumstances, some importers or distributors will need a Notified Body for their products.

Erik Vollebregt from Axon Lawyers will explain to us those cases and why this is important that importers and distributors are becoming on the scope of the authorities. If you have more questions on the topic, please send us a message as there are maybe some situations we didn’t discuss in this episode.

Who is Erik Vollebregt?

He actively contributes to law and policy development at the national and EU levels via membership of specialized committees at branch associations and the European Commission. Erik also works as an arbitrator in medical devices-related disputes and is regularly retained as an expert witness in foreign litigation. Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish.

Who is Monir El Azzouzi?

How to collect Clinical Data within the 21st Century [Jon Bergsteinsson]

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 21 Sep 2021 01:00:00 +0000

Clinical Data is key for the Medical Device Regulation MDR 2017/745. Today on this Podcast Episode, I have invited Jon Bergsteinsson from Smart Trial. And we will discuss Digital tools to collect data.

History of Clinical Data Collection
Difference between Big and small companies
Use of CRO for collecting data
Difference on Clinical Investigation and PMCF data collection

So if you still think that we should collect data by hiring people that are going to healthcare facilities and transfer data on paper or excel sheets then you should listen to this episode. The world is changing.

Who is Jon Bergsteinsson?

Jon co-founded the company behind SMART-TRIAL and served as the CTO until 2017, where he paved the way for the platform’s quality standard, data security, and compliance. With a background in Biomedical Engineering and 10 years of experience in clinical research and medical devices, Jón is mostly occupied with sharing valuable insights and know-how on clinical data management with the MedTech industry.

Who is Monir El Azzouzi?

How to manage the IVDR transition period? [IVDR 2017/745]

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 14 Sep 2021 00:00:00 +0000

We are at 9 months of the EU IVDR 2017/746 date of application. So let’s t talk of the Transition period for such products. We have done that also for MDR 2017/745 when the date was nearly due.

So today we’ll tell you about:

Differences between IVDD 98/79/EC and IVDR
The Hard Transition Period – The Soft Transition Period
The UDI transition period – The Notified Body situation
A simulation on submission timeline to a Notified Body

If you have any need of support for your projects don’t hesitate to contact me. I am sure we can help you.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.

He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses…

Is it a good idea to sue my Notified Body? [Erik Vollebregt]

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 07 Sep 2021 00:00:00 +0000

First of all, I am not encouraging anyone to sue anyone. This is only educative content to know what is possible and what is the best strategy to do it.

We will talk about the reason one company would sue its Notified Body and also about the good method and the bad method to do it. Some of the discussions are based on real-life experience. Anyway, one of the pieces of advice is to hire a lawyer specialized in Healthcare legislation so they can really understand how all this is working.

Long-life to Notified Bodies… !!!

Who is Erik Vollebregt?

Chambers Europe 2017: Erik is known for his specialism in regulatory work, which covers medical technology, devices, and products as well as biotechnology. Clients confirm his strong capabilities, with one saying “he stands out to me. Whenever I work with lawyers he has been the best, with a solid scientific background. He has the perfect combination of skills and experience.”

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.

He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, Online courses…

Links from the Video

Erik Vollebregt Linkedin Profile: https://www.linkedin.com/in/erikvollebregt/
Axon Lawyers: https://www.axonlawyers.com/
Erik’s blog: https://www.axonlawyers.com/author/erikvollebregt/?archive

The post Is it a good idea to sue my Notified Body? [Erik Vollebregt] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Medical Device News – September 2021 Latest Updates

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 31 Aug 2021 00:00:00 +0000

This month we will cover a lot of specific rules that are applied in some countries:

USA
UK
France
Finland
Switzerland

And then we’ll look at Events planned, Notified Bodies, MDCG guidances released, and the Podcast episodes.

Enjoy!

Who is Monir El Azzouzi?

Links from the Video

• HOT TOPICS

FDA Shifts to regulating Contrast agents as Devices: https://www.raps.org/news-and-articles/news-articles/2021/8/after-court-defeat-fda-shifts-to-regulating-some-d?utm_source=MagnetMail&utm_medium=Email%20&utm_campaign=RF%20Today%20%7C%209%20August%202021
UK – Export – FSC https://www.gov.uk/guidance/export-medical-devices-special-rules ○ Bfarm – Real time operating system vulnerabilities: https://www.bfarm.de/SharedDocs/Risikoinformationen/Medizinprodukte/EN/vulnerabilities_realtime_os.html;jsessionid=CBCADA5BC2C5210901042A54A3189117.intranet231?nn=968830
RAPS article on Bfarm alert: https://www.raps.org/news-and-articles/news-articles/2019/8/operating-system-vulnerabilities-in-many-medical-d
France: Anticipation potential disruption of products: https://ansm.sante.fr/actualites/indisponibilite-dun-dispositif-medical-lansm-publie-une-procedure-de-gestion-preventive-pour-les-operateurs-du-marche
Finland: MDR supplementing law: https://www.fimea.fi/web/en/-/laws-supplementing-eu-regulations-on-medical-devices-come-into-force
Switzerland – Obligation CH-REP importer distributors: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/market-access/pflichten-bevollmaechtigte.html
Easy Medical Device Authorized Representative: https://easymedicaldevice.com

• Events

GCC September 20th – 22nd – https://www.gccmedtech.com/
IMDS September 28th – 29th morning CET – https://www.imdsgroup.com/
Rentrée du DM October 6th – 7th – https://www.larentreedudm.com/
Medtech Virtual Summit October 18 – 22nd – https://informaconnect.com/medtech-summit/

• Notified Bodies

NB – GMED for IVDR: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.pdf&dir_id=35&ntf_id=314017

• Guidance and Standards

MDCG 2021-21 https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-21_en.pdf
MDCG 2021-22 https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-22_en.pdf
MDCG 2021-23 https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-23_en.pdf

• Podcast

Episode 140 – What can we learn from the first MDR audits? [Martin Witte – TÜV SÜD] https://podcast.easymedicaldevice.com/140/
Episode 141 – Better to be a Consultant of a Full-time employee? [Smahan Toughrai Tech’Firm] https://podcast.easymedicaldevice.com/141/
Episode 142 – How to certify a Software as a Medical Device? [Dr. Abtin Rad TÜV SÜD] https://podcast.easymedicaldevice.com/142/

The post Medical Device News – September 2021 Latest Updates appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

How to Certify a Software as Medical Device? (Dr. Abtin Rad – TÜV SÜD)

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 24 Aug 2021 00:00:00 +0000

Software as a Medical Device is really a difficult topic. First, because it is quite new in the EU Regulation, and second because we cannot make a generality and should consider each software one by one. In this episode, we asked directly a Notified Body to tell us exactly how we should view this field and what are the tips or warnings.

So I have invited Dr. Abtin Rad from TÜV SÜD to help us with this exercise. We will discuss with Abtin 3 main topics:

SaMD classification
Cybersecurity
Artificial Intelligence

And you’ll see that there are here a lot of tips for you to follow.

Who is Dr. Abtin Rad?

Abtin Rad has 13 years of professional experience as a Biomedical Electrical Engineer with a focus on Software, Cybersecurity, and Artificial Intelligence, as well as medical Imaging. Abtin Rad is a Cybersecurity and Artificial Intelligence Specialist for medical devices, as well as a Lead Auditor for ISO 13485, ISO 9001, MDSAP, and MDD/MDR. Currently, he is leading the digital topics at TÜV SÜD as the focus team manager.

Who is Monir El Azzouzi?

Links from the Video

Dr. Abtin Rad LinkedIn Profile: https://www.linkedin.com/in/dr-ing-abtin-rad-0601b744/
TÜV SÜD Website : https://www.tuvsud.com/en
TÜV SÜD Cybersecurity testing: https://www.tuvsud.com/en/industries/healthcare-and-medical-devices/medical-devices-and-ivd/medical-device-testing/physical-testing-of-medical-devices/medical-device-cybersecurity
TÜV SÜD Medical Devices Job board: https://www.tuvsud.com/en/careers/global-job-opportunities#/medical-devices-healthcare
TÜV SÜD Software Quality testing: https://www.tuvsud.com/en/services/testing/software-quality-testing
MDCG 2019-11 Software Qualification and Classification: https://ec.europa.eu/health/sites/default/files/md_topics-interest/docs/md_mdcg_2019_11_guidance_en.pdf
DRAFT EU Artificial Intelligence Regulation: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52021PC0206
ISO/TS 82304-2 :2021: https://www.iso.org/standard/78182.html
MDCG 2019-16 Cybersecurity for Medical Devices: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_cybersecurity_en.pdf
IEC/DIS 81001-5-1: https://www.iso.org/standard/76097.html
IEC TR 60601-4-5 :2021: https://webstore.iec.ch/publication/64703
Podcast Cybersecurity with Erik Vollebregt: https://podcast.easymedicaldevice.com/67/

The post How to Certify a Software as Medical Device? (Dr. Abtin Rad – TÜV SÜD) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Better to be a Consultant or a Full-time employee? [Lifescience industry]

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 17 Aug 2021 00:00:00 +0000

Let’s describe to you the life of a Healthcare industry consultant with Smahan Toughrai.

Within this episode, we will ask the question like:

Why would we choose a consultant job?
Should people have a certain skill to be a good consultant?
Is the salary a good motivation to be a consultant?
Is it better to work for a small company or a multinational?

If you also have a good or bad experience as a consultant, don’t hesitate to share that with us on the comments.

Who is Smahan Toughrai?

Smahan Toughraï is a senior consultant at Techfirm, currently working as a quality engineer for a major client in the pharmaceutical industry. Prior to that role, she has been active as an engineering consultant in the life sciences industry (pharma, biotech, hospitals) for the last 6 years at various clients all over Switzerland. Her expertise mainly consists in commissioning/qualification of equipment, cleaning, and process validation, as well as quality and compliance. Smahan has a background in chemistry and chemical engineering graduated from CPE-Lyon (France) and the University of Basel (Switzerland).

Who is Monir El Azzouzi?

What can we learn from the first MDR audits? [Martin Witte -TÜV SÜD]

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 10 Aug 2021 00:00:00 +0000

After few months of MDR, I proposed TÜV SÜD share with us the most common mistakes they find during their audits. And Martin Witte accepted to summarize some of them. So in this episode, you will hear the TOP 3 issues that are discovered so you can be prepared for it. You will see that some of them are obvious and others are more subtle.

Administrative work
Clinical evaluation
Biocompatibility

And Martin will also provide you some advice on how to be prepared for such an audit. He will also answer a bonus question which is: “Can we invite auditors to a restaurant or offer them a gift?” Don’t miss the links below related to what we discussed.

Who is Martin Witte?

Martin Witte is Senior Director Strategic Business Development at TÜV SÜD and responsible for the focus topics Active Medical Implants, Cardiovascular, Orthopedic, and Functional Safety/Software. Prior to his current role, Martin worked as a Lead Auditor, Product Specialist in TÜV SÜD from 2014 on, and took over business development activities with his role as the head of the Active Implants business in 2016. Prior to his roles in TÜV SÜD, Martin was a Regulatory Affairs Manager at BIOTRONIK, Berlin focusing on heart rhythm management devices and on MRI safety of such devices. His background is in Biomedical Engineering which he studied in Hamburg.

Who is Monir El Azzouzi?

Links from the Video

Martin Witte LinkedIn Profile: https://www.linkedin.com/in/martin-r-witte/
TÜV SÜD website: https://www.tuvsud.com/en
MDCG MDR Codes: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2019_14_mdr_codes_en.pdf
MDCG IVDR codes: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2021-14-guidance-ivdr-codes_en.pdf
MedBoard: https://www.medboard.com/
MDCG CEAR: https://ec.europa.eu/health/sites/health/files/md_sector/docs/mdcg_clinical_evaluationtemplate_en.pdf
CMR Articles: https://www.intertek.com/blog/2020-06-22-mdr/

The post What can we learn from the first MDR audits? [Martin Witte -TÜV SÜD] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Medical Device News – August 2021 Regulatory Update [MDR & IVDR]

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 03 Aug 2021 00:00:00 +0000

On the agenda for this month Episode we will talk about the latest news and here are few topics that I will present to you:

Team-NB Position Paper
Harmonized Standards
Free ISO standards
MHRA guidance on Software as Medical Devices
Training EU MDR
Green Belt in August
Notified Bodies situation
MDCG guidances
Easy Medical Device Podcast episodes

Don’t miss all the links at the bottom.

Who is Monir El Azzouzi?

Links from the Video

HOT TOPIC
- Team-NB position paper: Risk-based approach for medical devices exempted from an implant card and information to be supplied to the patients with an implanted device: https://www.team-nb.org/wp-content/uploads/2021/07/Team-NB-PositionPaper-ImplantCard-202107020.pdf
- Harmonized Standard IVDR: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32021D1195
- Harmonized Standards MDR: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32021D1182
- Episode 92 – How to prepare MDR audit with Martin Witte https://www.youtube.com/watch?v=Oa7jwL-HxgI
- EU Common list of Covid-19 Rapid antigen test: https://ec.europa.eu/health/security/crisis-management/twg_covid-19_diagnostic_tests_en
- Free ISO standards for Covid-19: https://www.iso.org/covid19?fbclid=IwAR1bUVGOr2Tv84Og4fiI0wsSCQi9XKD-Iw-j5QBifNZTTWKVluW1Kv8vqyw
- MHRA: Guidance on Medical Device Stand-alone software including apps: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/999908/Software_flow_chart_Ed_1-08b-IVD.pdf
- Green Belt Certification 14th Edition: https://school.easymedicaldevice.com/course/gb14/
NOTIFIED BODIES
- EU MDR Notified Body: Eurofins Product Testing S.r.l: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=313745&version_no=4
- EU MDR Notified Body: KIWA CERMET S.P.A.: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=313661&version_no=10
GUIDANCE AND STANDARDS
- MDCG 2021-20 – Instructions on generating CIV-IF for MDR Clinical Investigation: https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-20_en.pdf
- MDCG 2021-15 – Conformity assessment body. Application form applying for NB under MDR: https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-15_en.docx
- MDCG 2021-16 – Conformity assessment body. Application form applying for NB under IVDR: https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-16_en.docx
- MDCG 2021-17 – Conformity assessment body. Applied-for scope MDR: https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-17_en.docx
- MDCG 2021-18 – Conformity assessment body. Applied-for scope IVDR: https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-18_en.docx
- MDCG 2021-19 Guidance not integration of the udi within an organization Quality Management System: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_2021-19_en.pdf
- MDCG 2021-14 Explanatory note on IVDR codes: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2021-14-guidance-ivdr-codes_en.pdf
- MDCG 2021-13 rev 1 : Q&A EUDAMED registration: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2021-13_q-a-actor_registr_eudamed_en.pdf
EASY MEDICAL DEVICE activities
- Episode 136 – How to interpret the first Expert Panel Opinion? Bassil Akra https://podcast.easymedicaldevice.com/136/
- Episode 137 – System and Procedure Pack the RETURN with Erik Vollebregt https://podcast.easymedicaldevice.com/137/
- Episode 138 – How to implement Vigilance Reporting for MDR and IVDR https://podcast.easymedicaldevice.com/138/

The post Medical Device News – August 2021 Regulatory Update [MDR & IVDR] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

How to implement Vigilance Reporting for MDR and IVDR?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 27 Jul 2021 00:00:00 +0000

Within this Masterclass, I will explain to you how to implement a vigilance reporting system with all the links for all the documents we talk about.

Vigilance reporting is a system that you need to have in place for your Quality Management System even if you are still MDD compliant.

If you get a serious incident or a Field Safety Corrective Action (FSCA) then below are the steps to follow.

In this episode of the podcast, we will talk about

What to do when there is an incident?
When to report?
Who to report to?
How to report?
Investigation
Field Safety Notice
Significant Changes

Below you will have all the links.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.

He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses…

Links from the Video

Q&A MIR form https://ec.europa.eu/docsroom/documents/41322/attachments/1/translations/en/renditions/native
MIR Form: https://ec.europa.eu/docsroom/documents/41681/attachments/1/translations/en/renditions/native
FSN Form: https://ec.europa.eu/docsroom/documents/32521/attachments/1/translations/en/renditions/native
FSN – Customer reply: https://ec.europa.eu/docsroom/documents/32516/attachments/1/translations/en/renditions/native
FSN Distributor/Importer reply: https://ec.europa.eu/docsroom/documents/32517/attachments/1/translations/en/renditions/native
FSN Q&A: https://ec.europa.eu/docsroom/documents/31933/attachments/1/translations/en/renditions/native
IMDRF terminologies for categorized Adverse Event Reporting (AER): http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-200318-ae-terminologies-n43.pdf
IMDRF annexes: http://www.imdrf.org/documents/documents.asp
Periodic Summary Report (PSR) form: https://ec.europa.eu/docsroom/documents/32305/attachments/7/translations/en/renditions/pdf
IMDRF Trend Reporting Guideline: http://www.imdrf.org/docs/ghtf/final/sg2/technical-docs/ghtf-sg2-n36r7-2003-manufacturer-trend-reporting-adverse-event-030101.pdf
MDCG 2020-3 Significant changes: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_guidance_significant_changes_annexes_en.pdf
Medtech Europe revised Incident Reporting form: https://www.medtecheurope.org/news-and-events/news/revised-manufacturer-incident-reporting-form-and-new-vigilance-related-guidance-documents-published/
Cardiac implantable Electronic Devices (CIED) – Guidance on the vigilance system: https://ec.europa.eu/docsroom/documents/37283?locale=en
Breast Implants – Guidance on the vigilance system: https://ec.europa.eu/docsroom/documents/37283?locale=en

The post How to implement Vigilance Reporting for MDR and IVDR? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

System and Procedure Pack the RETURN with Erik Vollebregt

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 20 Jul 2021 00:00:00 +0000

In this second episode on System and Procedure Pack, we answer more questions about this way to place devices on the market. Erik got some experience with the authorities that he will share with us and I have created some cases that I will propose to Erik and see how he would manage them. Erik will also talk more about IVDR as this is a topic of high importance. Erik will also tell us more about his book. Follow the links for more details.

Who is Erik Vollebregt?

Erik specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software, and protection of personal data. He is an expert in life sciences regulation at the EU and Dutch level, with a focus on contracts, regulatory litigation against competent authorities, and M&A. Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms. He actively contributes to law and policy development at the national and EU levels via membership of specialized committees at branch associations and the European Commission. Erik also works as an arbitrator in medical devices-related disputes and is regularly retained as an expert witness in foreign litigation. Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish. Chambers Europe 2017: Erik is known for his specialism in regulatory work, which covers medical technology, devices, and products as well as for biotechnology. Clients confirm his strong capabilities, with one saying “he stands out to me. Whenever I work with lawyers he has been the best, with a solid scientific background. He has the perfect combination of skills and experience.”

Who is Monir El Azzouzi?

Links from the Video

Erik Vollebregt Linkedin Profile: https://www.linkedin.com/in/erikvollebregt/
Axon Lawyers: https://www.axonlawyers.com/
Erik’s blog: https://www.axonlawyers.com/author/erikvollebregt/?archive
Episode 119 System and procedure pack: https://podcast.easymedicaldevice.com/119/
MDCG EUDAMED Q&A: https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_mdcg_2021-13_q-a-actor_registr_eudamed_en.pdf

The post System and Procedure Pack the RETURN with Erik Vollebregt appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

How to interpret the first Expert Panel Opinion? [Bassil Akra]

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 13 Jul 2021 00:00:00 +0000

We received the First Expert Panel Opinion and by reading it you can say a lot. So to help us have a good interpretation of it, I have asked Bassil Akra to be my guest on this podcast episode.

We will remind you what is the Expert Panel, then we’ll discuss more deeply the Opinion received and finally, we will provide you some advice on how to avoid certain issues when you have to go through this process.

If you want to get this document, you have the link below.

Who is Dr. Bassil Akra?

Dr. Bassil Akra, CEO of Akra Team has a background in research, development, regulatory approval, and quality management of medical devices. Within his role at TÜV SÜD, Dr. Akra was a member of various Medical Device Regulation (MDR) European task forces, to help with the interpretation of the new legislation towards a smooth transition into May of 2020. In addition to his work as a senior field expert for TÜV SÜD, Dr. Akra presents worldwide on the European requirements and was involved in the development of many guidance documents and standards.

Who is Monir El Azzouzi?

Links from the Video

Akra team website: https://www.akrateam.com
Bassil Akra Linkedin Profile: https://www.linkedin.com/in/bassil-akra-2388b84b/
Episode 102 – What are expert panels with Bassil Akra: https://podcast.easymedicaldevice.com/102/
First Expert Panel Opinion: https://ec.europa.eu/health/sites/default/files/md_expertpanels/docs/2021-000201_nb0483_opinion.pdf
Clinical Pack: https://school.easymedicaldevice.com/product/clinical_pack/

The post How to interpret the first Expert Panel Opinion? [Bassil Akra] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Medical Device News: The July 2021 Update [MDR IVDR FDA SFDA]

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 06 Jul 2021 00:00:00 +0000

In this episode of the podcast, we will provide an update on the Medical Device industry for the period June July 2021.

Who is Monir El Azzouzi?

How to build your State-of-the-art for your Medical Devices?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 29 Jun 2021 00:00:00 +0000

State-of-the Art is an important topic but not well understood. It’s why I have invited Hakan Inan from Requalite to help us get a better understanding of this concept that you should use on your Clinical Evaluation or Performance Evaluation. We will talk not only about MDR but also about IVDR as this concept is required for both. Don’t hesitate to go on the show notes to see the documents that can help you with that.

Who is Hakan Inan?

Hakan Inan is the founder and the managing director of Requalite GmbH, Medical device compliance consulting company, with a special focus on Medical writing activities for Performance and clinical evaluation reports as per MDR and IVDR. Hakan holds a PhD in Nanotechnology and has developed in vitro diagnostic devices for cancer applications at Medicine Faculty-Stanford University. Requalite provides support to Medical device and In vitro diagnostic device companies in their compliance journey by designing and creating Performance and Clinical Evaluation Reports. Requalite has a strong team of experts, all with PhD degrees in the scientific fields including immunology, hematology, oncology, neurology, and cardiovascular diseases, etc.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert Specialised in Quality and Regulatory Affairs. He decided to quit his corporate job to start EASY MEDICAL DEVICE. He is now providing support to the Medical Device industry by educating people with his Blog, Podcast, Youtube channel and also helping them through consulting, coaching, and training. He decided to open an office in the UK to be able to support his customers that would need a UK Responsible Person. Easy Medical Device is becoming the one-stop-shop for Medical Device Industry.

How Intellectual Property is linked to the Medical Device Regulation?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 22 Jun 2021 00:00:00 +0000

In this episode of the podcast, I wanted an expert to answer the question about IP related to Medical Devices. A lot of people are willing to understand how intellectual property works when for example:

We have a Private Labeling Business
When we buy a product already designed by another company but place it on the market under your name?
When we want to mention “MADE IN” and a different country than where the product comes from…

Stephan Carter from UK is my guest today and he manages this type of situation for you. You will hear on this episode some advice that would really be beneficial to your business.

Who is Stephen Carter?

Stephen is a UK and European patent attorney and founder of The Intellectual Property Works. He is recognized by ‘IAM Strategy 300’ as one of the world’s leading IP strategists and is now focused on working with ambitious MedTech start-ups and SMEs to protect their innovations, helping them to succeed so they can make a positive impact in the world.

Who is Monir El Azzouzi?

How to perform a good Clinical Investigation with Helene Quie

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 15 Jun 2021 00:00:00 +0000

Clinical Investigation is one of the toughest process within the EU MDR 2017/745. If you have to perform one for your Medical Devices then it can be a long and expensive process.

In this episode, Helene Quie from Qmed Consulting, will help us understand how to perform it in a good way. This episode will answer some of the questions you have about Clinical Investigation and we hope this will make more clarity for you.

Some of the questions answered are:

Which products do need a clinical investigation?
Can we test our products on our employees without a clinical investigation?
How long does it take and how much does it cost?

Don’t hesitate to go below check the links on the different guidance.

Who is Helene Quie?

CEO at Qmed-consulting – experts in creating value-based documentation for innovative medical devices getting access to the markets through strong and honest partnerships with our clients.

It is my vision to enable better health through close collaborations with large established or newly started medical device manufacturers, small venture based innovative companies, venture funds, notified bodies, hospital, doctors and nurses within a wide range of medical device products and concepts from high-risk complex products such as heart valves with biological tissue to lower risk class products such as dental care products.

I believe that we through our trusted partners and colleagues can change the treatment of sick patients – making sure frontier products reach the patients and end-users, saving patient’s lives.

Together with the Qmed team, I have provided advice and/or operational services for several clients since 2006 within clinical and regulatory affairs, quality management, reimbursement, and health economics and market access with presence through our Qmed team and trusted partners in Europe, US, Canada, India, and Australia.

Who is Monir El Azzouzi?

He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses…

Link

Helene Quie Linkedin Profile: https://www.linkedin.com/in/helene-quie-863a323/
Qmed Consulting: https://www.qmed-consulting.com/
MDCG 2021-8. https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-8_en.pdf
MDCG 2021-6: https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-6_en.pdf
MDCG 2020-10: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2020-10-1_guidance_safety_reporting_en.pdf

The post How to perform a good Clinical Investigation with Helene Quie appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

How to perform a Biological Evaluation for your Medical Device?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 08 Jun 2021 00:00:00 +0000

We talked a lot about the regulatory requirements for your Medical Devices. Now let’s talk about something more technical which is the Biological Evaluation following ISO 10993-1 or also called Biocompatibility.

This is something that is key for the Medical Device Manufacturers but it is also not well understood. So Ana Luiza Cassin Duz, a Clinical Specialist for Medical Devices is helping us. She will answer all my questions on Biological Evaluation and I am sure there is something that will surprise you.

Don’t hesitate to ask your questions in the comments.

Who is Ana Luiza Cassin Duz?

She holds a Bachelor’s Degree in Biological Sciences, a Master’s Degree in Cellular Biology, a Ph.D. in Biological Sciences, and an MBA in Quality Management.

Who is Monir El Azzouzi?

He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses…

Medical Device News – June 2021 Update [EU MDR Date of Application]

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 01 Jun 2021 00:00:00 +0000

Ok, this month the EU MDR is LIVE so we will talk about that. The date of application for EU MDR 2017/745 was May 26th, 2021 and there is a lot of information that I will share with you.

We will talk about

EU MDD bye bye party
Webinars
EU MDR impact on other countries
Swixit
Turkxit
IVDR 2017/746
Notified Body Situation
MDCG guidance
IMDRF guidance
Podcast
Live session
Erik Vollebregt book

Links from the Video

HOT TOPICS

Portugal Inframed: https://www.infarmed.pt/web/infarmed/noticias/-/journal_content/56/15786/4404079
Italy: https://www.salute.gov.it/portale/news/p3_2_1_1_1.jsp?lingua=italiano&menu=notizie&p=dalministero&id=5499
Spain AEMPS: https://www.aemps.gob.es/informa/notasinformativas/productossanitarios/2021-productossanitarios/hoy-comienza-a-aplicarse-en-la-union-europea-el-nuevo-reglamento-de-productos-sanitarios/
Belgium AFMPS: https://www.afmps.be/fr/news/dispositifs_medicaux_reglement_2017745_applicable_des_aujourdhui
France Webinar ANSM: 2h French Webinar explanation EU MDR: https://ansm.sante.fr/evenements/reunion-dinformation-sur-le-nouveau-reglement-europeen-relatif-aux-dispositifs-medicaux-1
DG Health 2h Webinar for Patients – Safe and performant Medical Devices for all Webinar for Patients – Safe and performant Medical Devices for all
UDI Helpdesk: https://eu-udi.zendesk.com/hc/en-150
EMDN Nomenclature: https://webgate.ec.europa.eu/dyna2/emdn/
Ireland: HPRA new EU Device Legislation Information Pack http://www.hpra.ie/docs/default-source/default-document-library/hpra-eu-device-legislation-info-pack.pdf?sfvrsn=0
Australia: Consultation to change MD classification following EU MDR publication: https://www.tga.gov.au/medical-devices-reforms-reclassification-certain-medical-devices
JAMS Report: https://www.camd-europe.eu/wp-content/uploads/2021/05/JAMS-Layman-version-final-report-2020.pdf

SWIXIT

Revision of the Medical Device Legislation: https://www.bag.admin.ch/bag/en/home/medizin-und-forschung/heilmittel/aktuelle-rechtsetzungsprojekte/revision-med-prod-verord-mepv.html
New Regulation applicable to MD as of May 26th, 2021: https://www.swissmedic.ch/swissmedic/en/home/news/mitteilungen/neue-regulierug-mep-26-05-2021.html
New MedOD: https://www.fedlex.admin.ch/eli/cc/2020/552/en
Swiss SRN for Swiss Manufacturers, Authorised Representatives and Importer upon demand. https://www.swissmedic.ch/swissmedic/en/home/medical-devices/market-access/registriernummer-chrn.html
Notification of Medical Devices: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/market-access/meldung-medizinprodukten.html

TURKXIT

Team NB Letter to MDCG: https://www.team-nb.org/wp-content/uploads/2021/05/MDCG-Update_EU-Turkey-Customs-Union-Medical-Devices.pdf

IVDR 2017/746

IVDR: TEAM NB – CA for class D devices https://www.team-nb.org/wp-content/uploads/2021/05/Team-NB-PositionPaper-ClassD-20210519-V4.4.pdf

Standard and Guidance

MDCG 2021-09 – MDCG Position Paper on the Implementation of UDI requirements for contact lenses, spectacle frames, spectacle lenses & ready readers
MDCG 2020-18: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2020_18_en.pdf
MDCG 2021-08 Clinical investigation application/notification documents https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-8_en.pdf
MDCG 2021-7 Notice to manufacturers and authorised representatives on the impact of genetic variants on SARS-COV-2 in vitro diagnostic medical devices https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-7_en.pdf
IMDRF – PMCF Studies: http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-210325-wng65.pdf

EASY MEDICAL DEVICE

FDA: Is the Emergency Use Authorization worth it? Michelle Lott https://podcast.easymedicaldevice.com/127/
MDR is coming – Brace yourself Erik Vollebregt https://podcast.easymedicaldevice.com/128/
EU MDR Survey: What is the industry opinion? Catherine Higginson https://podcast.easymedicaldevice.com/129/
LinkedIn Live – All about PMCF with Cesare Magri https://www.youtube.com/watch?v=kq_c_hFhKeE
Erik Vollebregt Book -The Enriched MDR and IVDR: https://medicaldeviceslegal.com/2021/05/24/the-enriched-mdr-and-ivdr-finally-available/

The post Medical Device News – June 2021 Update [EU MDR Date of Application] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

EU MDR Survey: What is the Industry’s opinion? [Catherine Higginson]

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 25 May 2021 00:00:00 +0000

Last year we had reviewed the result of the EU MDR Survey made by Climedo and this year we check the difference. Do you think that there will be a big change?

Climedo has decided to ask questions related to the EU MDR but also to the context due to Coronavirus. So we are now looking at the result and you’ll see that there are some changes. But still the same on some of the most important topics.

Check below for the link on the last survey and this year’s one.

Who is Catherine Higginson?

Catherine started her career in the SaaS field in Corporate Communications for a B2B online language training company where she managed the company’s global marketing and PR activities. After almost four years, she switched to strategy consulting firm Oliver Wyman to help drive the company’s digital marketing and employer branding mission within Europe. In 2019, she joined Climedo Health, a software company that helps MedTech companies collect clinical data on their medical devices with the help of cloud-based solutions. As a bit of a “newbie” to the healthcare sector, she has enjoyed the steep learning curve offered by the startup world and creates regular content to help educate MedTech companies on matters such as electronic data capture and the EU MDR. She also carries out market research to assess the state of the industry in terms of MDR preparation and costs. Catherine studied Modern Languages (French and Spanish) at Newcastle University, followed by a Masters’s degree in Management at Warwick Business School.

Who is Monir El Azzouzi ?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. After working for many years with big Healthcare company and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

MDR is coming so brace yourself with Erik Vollebregt

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 18 May 2021 00:00:00 +0000

MDR is coming In 1 week and before that, I asked Erik Vollebregt from Axon Lawyers about some questions that I receive. We will talk about: – EU MDR IVDR postponement or not? – Economic Operators date of application – PRRC do we need it from day 1 – Exclusion from EU MDR – OEM OBL rules from May 26th, 2021 And Erik announces the content of its book that will be released soon. You will see on the following sections the links related to the topic we have discussed.

Who is Erik Vollebregt?

Erik specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software, and protection of personal data. He is an expert in life sciences regulation at the EU and Dutch level, with a focus on contracts, regulatory litigation against competent authorities, and M&A. Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms. He actively contributes to law and policy development at the national and EU levels via membership of specialized committees at branch associations and the European Commission. Erik also works as an arbitrator in medical devices-related disputes and is regularly retained as an expert witness in foreign litigation. Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish. Chambers Europe 2017: Erik is known for his specialism in regulatory work, which covers medical technology, devices, and products as well as biotechnology. Clients confirm his strong capabilities, with one saying “he stands out to me. Whenever I work with lawyers he has been the best, with a solid scientific background. He has the perfect combination of skills and experience.”

Who is Monir El Azzouzi?

Links from the Video

Erik Vollebregt Linkedin Profile: https://www.linkedin.com/in/erikvollebregt/
Axon Lawyers: https://www.axonlawyers.com/
Erik’s blog: https://www.axonlawyers.com/author/erikvollebregt/?archive
Qserve talks: https://open.spotify.com/episode/0iD2WYmfxzHYNpHvv6QH5J?si=iJtTJaUMTMGvecBUmfE3oQ
Blue Guide: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52016XC0726(02)&from=BG
Easy Medical Device Shop: https://easymedicaldevice.com/shop

The post MDR is coming so brace yourself with Erik Vollebregt appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

FDA: Is the Emergency Use Authorization worth it? (EUA)

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 11 May 2021 01:00:00 +0000

In this episode of the Podcast, we will explain to you what is the Emergency Use Authorization (EUA) that can be started in the US. And to help us, I have invited Michelle Lott from Lean RAQA.

This process was used a lot recently for Coronavirus products but you will see with Michelle that this process was changed so many times that it can create some headache.

Who is Michelle Lott?

Who is Monir El Azzouzi?

Link

Michelle Lott Linkedin Profile: https://www.linkedin.com/in/michellelottraqa/
Lean RAQA website: https://leanraqa.com/
FDA EUA Guidance: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

The post FDA: Is the Emergency Use Authorization worth it? (EUA) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Medical Device News – May 2021 Update [EU MDR 2017/745]

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 04 May 2021 00:00:00 +0000

Who is Monir El Azzouzi?

Checklist – What is important before the EU MDR Date of Application?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 27 Apr 2021 00:00:00 +0000

Wahoo!! We are close to it now. The EU MDR 2017/745 Date of Application is arriving quickly. So for this episode, I wanted to check with you if you are ready.

I will provide you first with the Scope for this date. Which products have to be ready by May 26th, 2021. Then we will talk about the documents that should be available. This list may not be complete so be sure to review for your product the requirements on the EU MDR. Finally we will talk about what is not mandatory even if people say it is.

Don’t miss also the links that I will provide below as this will help you to understand each of the topics.

Who is Monir El Azzouzi?

He has now developed the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

How to perform correctly a Merger & Acquisition during the MDR transition?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 20 Apr 2021 00:00:00 +0000

Subscribe

Merger and Acquisition sound like a financial topic but you’ll see that all the ways lead to Quality and Regulatory Affairs.

In this episode, Erik Vollebregt, Partner at Axon Lawyers will be helping us to understand why you should have some Quality and Regulatory affairs knowledge when you are running a Merger and Acquisition with a Medical Device company. This may be also more difficult due to the EU MDR transition period. So listen carefully.

Who is Erik Vollebregt?

He actively contributes to law and policy development at the national and EU levels via membership of specialized committees at branch associations and the European Commission.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.

He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses…

How to write your Performance Evaluation? [IVDR 2017/746]

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 13 Apr 2021 00:00:00 +0000

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In this episode I have invited Hakan Inan from Requalite to help us understand the situation for In-Vitro Diagnostic device manufacturers and also on how to create a Performance Evaluation Report.

In this episode Hakan will provide you all the elements so that you have a good understanding of the Performance Evaluation process. This will include also so comparison to the EU MDR legislation and define if there are some commonality.

The IVDR industry should start urgently its transition to the EU IVDR 2017/746 and most importantly we will need more Notified Bodies to help these companies to get certified.

Who is Hakan Inan?

Hakan holds a PhD in Nanotechnology and has developed in vitro diagnostic devices for cancer applications at Medicine Faculty-Stanford University.

Requalite provides support to Medical device and In vitro diagnostic device companies in their compliance journey by designing and creating Performance and Clinical Evaluation Reports. Requalite has a strong team of experts, all with PhD degrees in the scientific fields including immunology, hematology, oncology, neurology, and cardiovascular diseases, etc.

Who is Monir El Azzouzi ?

Monir El Azzouzi is a Medical Device Expert Specialised in Quality and Regulatory Affairs. He decided to quite his corporate job to start EASY MEDICAL DEVICE.

He is now providing support to the Medical Device industry by educating people with his Blog, Podcast, Youtube channel and also helping them through consulting, coaching, and training.

He decided to open an office in the UK to be able to support his customers that would need a UK Responsible Person.

Easy Medical Device is becoming the one stop shop for Medical Device Industry.

Links

Requalite Website: www.requalite.com
Linkedin: https://www.linkedin.com/in/hakaninan
Linkedinpage: https://www.linkedin.com/company/requalite-gmbh
Document Links for PER:
- http://www.imdrf.org/docs/ghtf/final/sg5/technical-docs/ghtf-sg5-n6-2012-clinical-evidence-ivd-medical-devices-121102.pdf
- http://www.imdrf.org/docs/ghtf/final/sg5/technical-docs/ghtf-sg5-n7-2012-scientific-validity-determination-evaluation-121102.pdf
- http://www.imdrf.org/docs/ghtf/final/sg5/technical-docs/ghtf-sg5-n8-2012-clinical-performance-studies-ivd-medical-devices-121102.pdf
- https://www.medtecheurope.org/wp-content/uploads/2020/05/MedTech-Europe-Clinical-Evidence-Requirements-for-CE-certification-eBook-2020.pdf

The post How to write your Performance Evaluation? [IVDR 2017/746] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Medical Device News – April 2021 Update [EU MDR & IVDR]

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 06 Apr 2021 00:00:00 +0000

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Let’s update you on the Medical Device situation. In this episode we will talk about:

Countdown until date of application of EU MDR
Swixit with a negociation ongoing
MDCG guidance planning
Easy Medical Device services
Notified Body overview
UK Approved Body overview
EU commission guidance on SaMD
MDCG 2021-2 on Covid-19 Rapid test
MDCG 2021-3 on Custom-made devices
Easy Medical Device Podcast
Easy Medical Device Live sessions

See below the links for each of the topics.

Who is Monir El Azzouzi

Will it be really difficult for IVD manufacturers? [IVDR 2017/746]

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 30 Mar 2021 00:00:00 +0000

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We talked a lot about the EU MDR and the difficulty for some manufacturers to transition to this new legislation. But today we will explain why IVDR manufacturers will struggle more. I will explain to you the change in terms of product classification within the IVDR 2017/746. Because of this, a lot of manufacturers that didn’t need a Notified Body before will need one now. And as you may know, as of today, the number of Notified Bodies is not really high. So I hope this episode will help you understand the situation for the IVD business as there is a risk for manufacturers but also for patients.

Who is Monir El Azzouzi?

How to create a Label under MDR? (Questions & Answers)

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 23 Mar 2021 00:00:00 +0000

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This podcast episode is following a presentation I have made during the Greenlight Guru Summit on EU MDR and IVDR. I have explained how to create a label that fulfills the requirements of the EU MDR. I have placed on the show notes the link to it. After the session, I have received a lot of questions and I didn’t have the time to answer all of them, so I said to myself that maybe it would be better to have 1 podcast episode instead of me answer per email to each person. I am sure that the question people asked is common to other persons so let’s review that together.

Who is Monir El Azzouzi?

How System and Procedure Pack are regulated under EU MDR?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 16 Mar 2021 00:00:00 +0000

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Let’s discuss System and Procedure Pack. We usually talk about medical devices like as an object that is used in the healthcare industry. But when you have to combine multiple objects, how can you then regulate that. Is there one classification for all or should you classify and register each of them. And what if all these objects are already CE marked?

So this episode will try to help you understand the legislation for these types of products described in article 22 of the EU MDR 2017/745 regulation on system and procedure pack. We will also mention the KITS that are described in the EU IVDR 2017/746 to show if there is an equivalent for in-vitro diagnostics

Who is Erik Vollebregt?

He actively contributes to law and policy development at the national and EU levels via membership of specialized committees at branch associations and the European Commission.

Who is Monir El Azzouzi?

He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses…

He proposes also the service of the UK Responsible Person and EU Representative. If you need any support for your Quality and Regulatory Affairs activities, don’t hesitate to contact him.

How to import your Medical Devices with an Independent Importer?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 09 Mar 2021 00:00:00 +0000

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With the EU MDR 2017/745 and IVDR 2017/746 the role of Economic Operators is becoming clearer. In the case you are located outside of Europe and you need to import your Medical Devices in the EU, you need to have an Importer.

In this episode we will talk of the importer role and what they need to check before your product is placed on the EU market.

And then we will explain the model of Independent Importer which is an entity that is not touching your products but they are still liable for any product on the Market.

This is what Edgar Kasteel from MedEnvoy will try to explain to us.

Who is Edgar Kasteel?

Edgar is an international business development expert and has many years of experience supporting European, American and Asian manufacturers of medical devices and IVDs in establishing or expanding their business across the globe.

Luctor Medical focuses on market entry from a commercial point of view. MedEnvoy assists manufacturers to meet the Importer obligations related to the upcoming MDR and IVDR.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.

He has created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, Online courses…

Link

Edgar Kasteel LinkedIn Profile: https://www.linkedin.com/in/edgar-kasteel-0551b71/
MedEnvoy website: https://www.medenvoyglobal.com/
Blue Guide CE marking: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52016XC0726(02)&from=BG
Economic Operators blog post: https://easymedicaldevice.com/economic-operators/

The post How to import your Medical Devices with an Independent Importer? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

What is the Medical Device News? [March 2021 update]

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 02 Mar 2021 00:00:00 +0000

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This month we will review what happened within the Medical Device Industry and there was some updates.

Here is the agenda:

EUDAMED
Covid19
Language for EU MDR 2017/745
MHRA virtual manufacturer update
Australia Nanoparticle consultation
Singapore Medical device grouping tool
Saudi Arabia covid 19 update
Easy Medical Expert
Green Belt Training
Notified Bodies
Approved Bodies
Events
Podcast episodes

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.

He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

The best design methods for successful development? [Jon Speer]

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 23 Feb 2021 00:00:00 +0000

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I am really honored to have within this episode of the Podcast Jon Speer. I was already following him before I started Easy Medical Device and now I had the opportunity to interview him.

We discussed Medical Device Design, and I wanted his opinion on the best design methodology to use and which trap to not fall in.

We discussed particularly the famous FDA waterfall diagram and the Agile methodology.

So if you are a company developing Medical Devices, this is an episode that you should not miss.

Who is Jon Speer?

Jon Speer is the founder of Greenlight Guru, a medical device quality management software solution.

Jon is a medical device guru with over 22 years of industry experience who knows the best medical device companies in the world use quality as an accelerator.

That’s why he created Greenlight Guru to help companies move beyond compliance to achieve True Quality.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.

He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, Online courses…

Lately, Monir created the Easy Medical Expert platform where you can submit some missions, and experts in the Medical Device field will be able to answer and help you.

How to find a QA RA job for Medical Devices? [Karandeep Badwal]

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 16 Feb 2021 00:00:00 +0000

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If you find it difficult to get a job in QA RA for Medical Devices, then listen to this episode where Monir El Azzouzi and Karandeep Badwal are giving you some tips on how to integrate this world.

They will provide you some tools to use, some podcasts to listen to, some groups to follow. And for sure this will move you few steps forward. If you have any questions, don’t hesitate to ask in the comments.

Who is Karandeep Badwal?

Mr. Karandeep Singh Badwal is a Regulatory and Quality Contractor specializing in medical devices.

His educational background is an MSc Pharmaceutical Quality by Design, however, has worked almost exclusively within the medical devices industry from multinational companies to startups since his graduation.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.

He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

What is the QA RA Mindset with Michelle Lott

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 09 Feb 2021 00:00:00 +0000

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Michelle Lott and I are discussing our Experience in the Quality and Regulatory affairs area. We will help you define what is compliance and how we think it should be applied. Michelle had also some good and bad experiences that she is sharing with us.

Who is Michelle Lott?

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. After working for many years with big Healthcare companIES and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

Links from the Video

Linkedin Michelle Lott: https://www.linkedin.com/in/michellelottraqa/
Lean RAQA Website: https://leanraqa.com/
Lean RAQA Today Podcast: https://soundcloud.com/raqatoday
Blog Post “What is Quality?”: https://easymedicaldevice.com/what-is-quality/

The post What is the QA RA Mindset with Michelle Lott appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

February 2021 Update – Medical Devices Remote Audit by the EU

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 02 Feb 2021 00:00:00 +0000

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In this monthly episode of the podcast, we do a regulatory intelligence review of what happened monthly.

The agenda for this month is:

Countdown until EU MDR by Michelle Lott (LeanRAQA)
Remote Audit authorized for EU MDR
SURVEY Result
US update on Recognised Consensus Standards
Canada guidance on Vigilance Reporting
Training available
Notified Body Situation
UK Approved Body
Guidance and Standards
PODCAST and LIVE episodes

Look at all the links below.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.

He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

How to perform your PMS more easily with Ivan Perez Chamorro?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 26 Jan 2021 00:00:00 +0000

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PMS is one of the processes that is changing due to EU MDR and I wanted to come back to it with Ivan Perez Chamorro from MedBoard.

MedBoard is a solution that helps you with your Regulatory Intelligence. And Ivan is trying to make the life of the companies easier by providing some tools. In this episode, Ivan will first explain to us what is PMS and how this is working. And then how a digital solution can help.

Don’t hesitate to try MedBoard as this is free for the first 3 weeks.

Who is Ivan Perez Chamorro?

Ivan has both strong science and business background, he holds a degree and MSc in Physics from Universidad de Salamanca, and an MBA from IE Business School. Ivan is very active in medical device industry, and he is also part of the TOPRA MedTech SPIN.

After having a chronic sports injury while playing basketball, and spending many years in rehabilitation, he decided after physics graduation to work in the medical devices industry. Ivan has lived in different countries and likes travelling, painting, and adventure sports, and has special interest in innovation, entrepreneurship, and technology. MedBoard is not the first project, and Ivan has have a number of entrepreneurship projects in the past, in the medical and outside of medical devices industry.

Before Medboard, Ivan had worked for many years within the industry, as an employee of leading medical companies and as a consultant in the areas of product and business development, regulations, and strategy, from operational roles to advising technical and top management. He has broad experience with different types and classes of medical devices and combination products, supporting a variety of organization models, from start-ups to large corporations.

Who is Monir El Azzouzi?

TextMonir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. After working for many years with Big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world.

He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

Link

Ivan’s LinkedIn Profile: https://www.linkedin.com/in/ivan-perez-chamorro-804b0b22/
MedBoard link: http://www.medboardco.com/your-medboard/news-feed/
Podcast episode PMS: https://podcast.easymedicaldevice.com/41/

The post How to perform your PMS more easily with Ivan Perez Chamorro? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

How to get the MDR certification for Artificial Intelligence Softwares?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 19 Jan 2021 00:00:00 +0000

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Artificial Intelligence. This is the topic of today’s podcast episode. We will help you understand how to place AI Software as a Medical Device in the EU Market with the new EU MDR 2017/745.

For that, I have with me Leon Doorn from Aidence who is explaining to us its journey to get EU MDR 2017/745 certified. You will first understand what is really artificial intelligence, then we will talk about the classification of SaMD or Software as Medical Devices.

Leon will also tell us what went well and what was really a struggle for him. We will also talk about the Notified Body support. So if you are a company that develops SaMD or AI software then this episode is for you.

Don’t hesitate to contact Easy Medical Device (info@easymedicaldevice.com) if you have some SaMD project. We can help you with it.

Who is Leon Doorn?

Leon is responsible for Regulatory Affairs within Aidence, a scale up company, who are developing AI solutions to detect abnormalities in imaging. He is working for over 12 years in the medical industry, within the quality and regulatory field and has gained his specific knowledge on Artificial Intelligence while working at Aidence.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.

After working for many years with a big Healthcare company and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world.

He has now created the consulting firm Easy Medical Device and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

How to register a Medical Device in Israel? (Liat Nadel)

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 12 Jan 2021 00:00:00 +0000

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Registration of products in different countries is always a Challenge. And for Israel, this is the same.

I have invited Liat Nadel from L.S. Marketing & Registration to help us understand the situation and how to succeed in the registration process. We will talk also about the possibility to use registrations already done in Europe and the US to be able to accelerate the process.

Liat will also share with us the services that she will provide to be able to support you on this project.

Who is Liat Nadel?

Liat holds a BA Degree in Biologics , Master of Law/ degree from Bar Ilan University Israel / a Jurist . A multidisciplinary/ experienced professional in the medical device industry & has a rich background & in- depth knowledge, over 20 + years in Israel & worldwide.

Focus: Regulatory Affairs, QMS, Import-export, Business Development, Law. Liat has managed RA departments in various medical devices companies in Israel such as Tzamal Medical Group, Omrix Biopharmaceuticals Ltd. / today J& J.

Liat also has vast experience in foreign relations (she speaks German, English, French Hebrew, Arabic).

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.

He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

Medical Device News – January 2021 Update (Monir El Azzouzi)

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Tue, 05 Jan 2021 09:00:00 +0000

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HAPPY NEW YEAR 2021 and all my best wishes to you and your family.

Within this Medical Device News monthly episode of the podcast, we are reviewing the situation on:

Brexit and the need for UK Responsible person
Swixit and Turkxit
EUDAMED and PRRC information made public
Team NB position papers
Training – Notified Body situation
UK Approved Body situation
MDCG guidance
Podcast review

Don’t forget that Easy Medical Device can be your UK Responsible Person or also your EU REP contact us at UKREP@easymedicaldevice.com

Who is Monir El Azzouzi?

How Easy Medical Device can help you? (Monir El Azzouzi)

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 28 Dec 2020 00:00:00 +0000

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In this episode of the Medical Device made Easy Podcast, I will share with you the progress of the Easy Medical Device project.

I hope this will be helping the medical device community and if you need more support, please ask me. I am really here to help you. We will talk about:

Podcast
Training
Consulting
Coaching
Authorized Representatives
Easy Medical Expert

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.

After working for many years with big Healthcare company and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world.

He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

Lastly he also created Easy Medical Device UK to be the UK Authorized Representative for its customers.

How to deal with Significant Changes within MDR & IVDR with Martin Witte

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 21 Dec 2020 00:00:00 +0000

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If you are transitioning from the EU MDD 93/42/EC or 90/385/EEC to the EU MDR 2017/745 or from the IVDD 98/79/EC to the IVDR 2017/745, then you have to be careful with Significant Changes.

In this episode, I’ve asked Martin Witte from TÜV SÜD to give us the point of view of Notified Bodies on Significant changes. When we should consider them, what are the best practices, what to do when we deal with a significant change, and what are the consequences if we are not following the regulation.

So this will be an excellent episode to help you prepare your procedures for significant changes and understand the risks.

Who is Martin Witte?

Martin Witte is Senior Director Strategic Business Development at TÜV SÜD and responsible for the focus topics Active Medical Implants, Cardiovascular, Orthopedic, and Functional Safety/Software.

Prior to his roles in TÜV SÜD, Martin was a Regulatory Affairs Manager at BIOTRONIK, Berlin focusing on heart rhythm management devices and on MRI safety of such devices. His background in Biomedical Engineering which he studied in Hamburg.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.

He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

Link

Martin Witte LinkedIn: https://www.linkedin.com/in/martin-r-witte/
TÜV SÜD Notified Body page: https://www.tuvsud.com/en
TÜV SÜD application form: https://bit.ly/3i2Ahnl
Episode 92- Prepare your MDR audit: https://podcast.easymedicaldevice.com/92
MDCG 2020-3: Significant changes for your Medical Device: https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_mdcg_guidance_significant_changes_annexes_en.pdf

The post How to deal with Significant Changes within MDR & IVDR with Martin Witte appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

How to register a Medical Device in Mexico? [Josué Garza]

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 14 Dec 2020 00:00:00 +0000

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The registration of Medical Devices is always different and this time we will explain to you how you can do that in Mexico.

For that I have invited to the Medical Device made Easy Podcast, Josué Garza from Insumos para la Salud or IPS.

Josué will explain to us the pathways needed to register your Medical Devices in Mexico. He will also give you some advice regarding the Ministry of health.

Who is Josué Garza?

Josué Garza is the Director of Business Development & Operations at Insumos para la Salud (IPS), a regulatory affairs consulting firm helping medical device manufacturers and distributors obtain market access in Mexico.

Josué has over 10 years of experience working with the private sector, government and nonprofit organizations. Before joining IPS, he took leadership positions in the International Republican Institute, Consulate General of Mexico in Atlanta, Premier Destination Services and the Institutional Revolutionary Party.

Josue has expertise in managing projects at the municipal, state and national levels, participating in public policy initiatives, and developing strategies through team-centered processes.

Today, he continues to influence the growth of IPS by helping businesses from around the world thrive in Mexico and improve access to the best health products for Mexicans.

Josué holds a BA in International Relations from Universidad Iberoamericana. He spends most of his time in Chicago and Mexico City.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.

He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

Medical Device News: What happened in November 2020?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 07 Dec 2020 00:00:00 +0000

In this monthly review of Medical Device News, we will see what happened this November 2020 for the Medical Device Industry.

During this review, we will check some topics like:

Eudamed
Quality engine
Brexit and UK responsible Person
TEAM NB Position paper with some proposals
Job Opportunities in EU and the US
Greenlight Guru event
TOPRA Award: Who is the winner
Notified Body situation
Guidance
Podcast episodes

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.

He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

Links from the Video

HOT TOPICS

EUDAMED Actor module FAQ: https://ec.europa.eu/health/sites/health/files/md_eudamed/docs/md_actor_module_q-a_en.pdf
Link EUDAMED Registration: https://webgate.ec.europa.eu/eudamed
Quality Engine: https://quality-engine.com/
Easy Medical Device UK Responsible Person: https://easymedicaldevice.com/uk-responsible-person/
Brexit communication: https://www.gov.uk/guidance/regulating-medical-devices-from-1-january-2021
TEAM-NB Position paper: https://www.team-nb.org/wp-content/uploads/2020/11/Team-NB-PositionPaper-Team-NB-consideration-paper-on-IVDR-Date-of-Application.pdf
Job ELEMED: https://www.elemed.eu/vacancies/
Job Life Science People: https://www.lifesciencepeople.co.uk/jobs
Job The Anthony Michael Group: https://www.theanthonymichaelgroup.com/opportunities/
TOPRA Award Ceremony: https://www.youtube.com/watch?v=vKJFEFCrrEg
Greenlight Guru Virtual Event: https://2021md.greenlight.guru/?sc=XX1H2oPX&ac=gJxS6x7K
Green Belt Certificate: https://school.easymedicaldevice.com/gb

NOTIFIED BODIES

UDEM Adriatic: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.nb&body_type=NB&refe_cd=NANDO_INPUT_232844

GUIDANCES

Agenda for MDCG meeting: https://ec.europa.eu/health/sites/health/files/md_dialogue/docs/md_events_2021_en.pdf

MDCG 2020-16 Classification rules for IVDR: https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_mdcg_2020_guidance_classification_ivd-md_en.pdf

PODCAST EPISODES

Episode 100 – Last 2 years story: https://podcast.easymedicaldevice.com/100/
Episode 101: Common Specifications with Stefan Bolleininger: https://podcast.easymedicaldevice.com/101/
Episode 102: Expert Panels with Bassil Akra: https://podcast.easymedicaldevice.com/102/
Episode 103: Training benefits with SOFMEDICA Team: https://podcast.easymedicaldevice.com/103/
Episode 104: Notified Body accreditation with Caroline Dore Geraghty: https://podcast.easymedicaldevice.com/104/

The post Medical Device News: What happened in November 2020? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Is it Easy for a Notified Body to get EU MDR accredited?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 30 Nov 2020 00:00:00 +0000

We talk a lot about Manufacturers that are under pressure because they cannot find a Notified Body, but today we will also talk about the pressure on Notified Bodies.

Caroline Dore Geraghty, Director of Medical Devices at NSAI is my guest and she will tell us more about the process for Notified Bodies to get accredited. NSAI is an Irish Notified Body and it received its accreditation for EU MDR and can now help its customer.

We will talk about:

The process to get accredited
The possibility to certify the company for EU MDD 93/42/EC
The action of the Notified Bodies during the transition period after the date of application (May 26th, 2021)
The different services that NSAI can offer

NSAI is also looking for auditors so don’t hesitate to contact NSAI if you are interested.

Who is Caroline Dore Geraghty?

Dr. Caroline Dore Geraghty is the Director of medical devices and Head of the notified body. Caroline graduated from the Royal College of Surgeons in Ireland as a medical doctor in 2002 and worked clinically for 12 years.

She holds a masters of science degree in allergy and a diploma in dermatology.

Caroline was head of the clinical team in NSAI for 4 years prior to her promotion to director of the medical devices department.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.

He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

Links from the Video

Caroline Dore Geraghty LinkedIn: https://www.linkedin.com/in/caroline-dore-geraghty-33117452/
NSAI website: https://www.nsai.ie/certification/medical-devices/
Join NSAI: https://www.nsai.ie/about/work-with-us/
Episode 92 – Notified Body audit: https://podcast.easymedicaldevice.com/92/

The post Is it Easy for a Notified Body to get EU MDR accredited? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

How a Quality & Regulatory training can help you? [Sofmedica]

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 23 Nov 2020 00:00:00 +0000

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I had the chance to train many people to EU MDR and I am always proud to see them implementing what they have learned. And today I want to tell you the story of the company Sofmedica.

This is an Importer and Distributor in Europe and they have participated in the Green Belt Certificate. This is the training on EU MDR that Easy Medical Device is proposing. I have interviewed 3 of their QA RA employees with Cristina Miroescu, Rodica Paslaru, and Katerina Pappa.

Training is something important. As Katerina Pappa said, reading the text is not sufficient, you have to test your knowledge and check that you have really well understood. So for those that are hesitating to take training, this podcast episode will help you understand the benefit of such investment. If you also want to participate in the Green Belt Certificate, please check the next session at https://school.easymedicaldevice.com/gb/

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. After working for many years with a big Healthcare company and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

Do you need an Expert Panel for your Medical Devices? [Bassil Akra]

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 16 Nov 2020 00:00:00 +0000

The EU MDR 2017/745 is increasing the requirements for Clinical Evaluations. In this episode, I will be with Dr. Bassil Akra from QUNIQUE and we will explain to you the different levels of reviews that exist and specifically about the Expert Panel.

You would maybe ask “What is this?”.

Don’t worry, we will explain to you and even provide you with more information also on some voluntary consultation that this group can provide.

In case you need some support for your Clinical Evaluation Reports, UK responsible process, Technical File review, Training for EU MDR, don’t hesitate to contact us at info@easymedicaldevice.com We can guide you on this process.

Who is Dr. Bassil Akra?

Dr. Bassil Akra, Co-owner and CEO of QUNIQUE Group has a background in research, development, regulatory approval, and quality management of medical devices.

Within his role at TÜV SÜD, Dr. Akra was a member of various Medical Device Regulation (MDR) European task forces, to help with the interpretation of the new legislation towards a smooth transition into May of 2020.

In addition to his work as a senior field expert for TÜV SÜD, Dr. Akra presents worldwide on the European requirements and was involved in the development of many guidance documents and standards.

In his new role as Co-owner and CEO of QUNIQUE Group, he will now be also able to support Medical Device manufacturers through consulting and training.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.

He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

What are Common Specifications under EU MDR & IVDR?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 09 Nov 2020 00:00:00 +0000

What are Common Specifications? Is this the same as ISO standards or any other guidance? This is what we will review within this episode with Stefan Bolleininger. In the EU MDR and IVDR, Common Specification is mentioned and it is a tool that the EU Commission can use.

But are you obliged to use them? In this episode, we will talk about a few common specifications. 1 published, 1 under draft, and some that are supposedly planned.

And we can see also that some of the provisions of the EU MDR cannot be applied without the publication of some common specifications.

So even if you think you are not impacted by Common Specification, you maybe need to re-evaluate that after listening to this episode.

Who is Stefan Bolleininger?

Stefan Bolleininger is a key opinion leader and speaker for the medical device regulation MDR in Europe.

He founded the be-on-Quality GmbH consulting agency to passionately support manufacturers during CE approvals or FDA approvals. This support covers the full chain of quality and regulatory requirements: Implementation, maintenance, audits, assessments, and inspections.

In the area of “Risk Management and Usability for Medical Devices and Medical Networks”, he holds a teaching assignment at the Technical University of Nuremberg and the VDI Technical Committee “Quality Assurance for Software in Medical Devices”.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.

He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

We’ve reached episode 100 – What happened for the last 2 years?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 02 Nov 2020 00:00:00 +0000

We have reached Episode 100 and when I am looking back, I can see that there were a lot of things done. But instead of me telling you only my story, I have decided to invite some of my guests to tell us also their stories from the last 2 years.

So, I will introduce you 5 stories from 5 influencers in the Medical Device field.

Erik Vollebregt – Partner at Axon Lawyers
Bassil Akra – CEO and co-owner at QUNIQUE Group
Stefan Bolleininger – CEO at Be-on-Quality
Martin Witte – Sr. Director Business Development at TÜV SÜD
Richard Houlihan – CEO at EUDAMED.EU

If you also want to share with us your highlight for the last 2 years, don’t hesitate to put that on the comments.

Who is Monir El Azzouzi?

How to certify a self-testing device under IVDR? [Erik Vollebregt]

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 26 Oct 2020 00:00:00 +0000

We have talked enough about EU MDR so this week we will help the IVD Companies with the requirements for Self-testing devices under IVDR. Self-tests or near-patient tests are problematic because they are used by laypersons which are not professionals on the way to use or interpret the result of such a device.

So, some particular care is provided by the regulators to verify that a layperson really understands how these device work and to avoid some misinterpretation.

Erik Vollebregt will be helping us to understand this situation and we will also talk about certain stories we were experimenting with.

Who is Erik Wollebregt?

Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission.

He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms. He actively contributes to law and policy development at the national and EU levels via membership of specialized committees at branch associations and the European Commission. Erik also works as an arbitrator in medical devices related disputes and is regularly retained as an expert witness in foreign litigation.

Clients confirm his strong capabilities, with one saying “he stands out to me. Whenever I work with lawyers he has been the best, with a solid scientific background. He has the perfect combination of skills and experience.”

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.

He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

Links from the Video

Erik Vollebregt LinkedIn Profile: https://www.linkedin.com/in/erikvollebregt/
Axon Lawyers: http://www.axonlawyers.com/
Presentation to download: https://mailchi.mp/easymedicaldevice/g5poc37919
Episode 42 – New rules for the IVD industry with Maurizio Suppo: https://podcast.easymedicaldevice.com/42/

The post How to certify a self-testing device under IVDR? [Erik Vollebregt] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

What is the cost of EU MDR 2017/745? [Catherine Higginson]

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 19 Oct 2020 00:00:00 +0000

Catherine Higginson from Climedo is coming on the Podcast to present us one study they have issued which will tell you more about the Cost of EU MDR but not only that.

This is showing the investment that companies are doing regarding EU MDR:

Time investment
Resource investment
Money investment

It is also showing some data related to the digitalization of their companies regarding some activities like the collection of Clinical Data. Some of them are still using Excel to do that which is maybe not the most convenient solution.

You will have access to this survey by checking the links below.

About Climedo Health

Climedo’s mission is to bring the best treatment to every patient by empowering healthcare professionals with intelligent software solutions. Together with Europe’s leading hospitals, we have developed a cloud-based platform for cutting-edge clinical validation and post-market surveillance of medical devices and pharmaceutical products. By digitally connecting all stakeholders (Medical Device manufacturers, Pharma companies, CROs, hospitals, and patients), Climedo allows for increased performance, better cost-efficiencies – and ultimately – accelerated medical innovation.

Who is Catherine Higginson?

Who is Monir El Azzouzi?

How to register your Medical Device in the ASEAN region?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 12 Oct 2020 00:00:00 +0000

The focused region is the region that agreed to follow the ASEAN regulation. ASEAN means the Association of South East Asia Nations.

In this episode of the podcast, Michael Wetherington will help us to have a better understanding of how to register your products in this region.

You will see that there are some differences with the fact that even if all countries are following the same directive, there can be still some differences. And also that having a Partner in the region can help you save a lot of time and money.

Fortunately, MedicalReg,com can help you so don’t hesitate to contact Michael Wetherington if you need any support. As said in this episode he proposes his service to help manufacturers that try to reach this region.

Don’t forget to check the links below to understand more about this directive.

Who is Michael Wetherington?

His background encompasses medical device R&D, accredited testing lab, and Notified Body experience. He is also a mentor at Elemed’s Mentoring Academy. And, when time permits, he likes to sing, play the drums, and the guitar.

Who is Monir El Azzouzi?

Finally, he has created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

The latest news on Brexit, Swixit and EU MDR [Medical Device News]

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 05 Oct 2020 00:00:00 +0000

This month on the Medical Device News section of the podcast we will talk about:

Exits from Europe with Brexit and Swixit
Conferences that are now mainly going virtual
Green Belt Certification
Celebrations
Notified Body situation with the countdown offered by Michelle Lott
Standards and guidances
Podcast

Don’t hesitate to look at the Medical Device News links in the below section to review more in detail each topic.

Don’t forget also to participate in the Green Belt certificate so you can learn more about EU MDR.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.

Recently, he has created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

How to register ATMP-Device combination products?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 28 Sep 2020 00:00:00 +0000

ATMP stands for Advanced Therapy Medicinal Products, which is a category of Medicinal Product. But if I combine this with a Medical Device, how should this be regulated and how can I register this product in Europe?

Effectively, this is exactly the question that Margareth Jorvid from Methra Uppsala AB will help us to answer. So if your product is combined with a Medical Device, you should listen to that.

Remember, we had a previous episode specifically on combined products Drug-Device but here you’ll see that the process is a bit different.

To help you understand, we will review the requirements of the 1394/2007 regulation. It contained already requirements on how to manage ATMP-device combined products.

Who is Margareth Jorvid?

Margareth Jorvid has over 30 years of experience in Regulatory Affairs and has worked at the Swedish Medical Products Agency (MPA) as well as large and small pharmaceutical and biotech companies, such as Roussel Nordiska, Hoechst Marion Roussel (in Stockholm and Paris, France) and Neopharma.

Since 2006, consultant in regulatory affairs and QA for pharmaceuticals, ATMP (cell- and gene therapies), medical devices, and combination products through her company Methra Uppsala AB, LSM group.

Additionally, she is a member and honorary member of TOPRA (Organisation for Professionals in Regulatory Affairs), previous board member, and TOPRA president from 2005-2006.

She holds a MSc Pharm from Uppsala University, a MBA from Stockholm School of Economics, Sweden, and a MSc MTRA from Cranfield University, UK.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.

Recently, he has created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

How to get some help from Medical Device Regulators with Cliff Bleustein

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 21 Sep 2020 00:00:00 +0000

In this episode, Cliff Bleustein, President and CEO of Apos Therapy is explaining to us all the process that his company followed to place his Medical Device on the market.

One of the most important advice was to get support from the regulators. They are the most reliable source of information so you can go in the right direction. FDA is providing this possibility to meet regulators and then be able to receive some feedback. This saves time and money for the company but also to the regulators.

Cliff explains to us also the way medical device companies can get Clinical Data for its product. Learn more about Apos Therapy with the links below.

Who is Cliff Bleustein?

Dr. Clifford Bleustein is the Global President and CEO of AposTherapy. Prior to AposTherapy, Dr. Bleustein was President and CEO of Computer Task Group (NASDAQ: CTG) where he managed more than 3400 people globally and more than $340M in revenue across healthcare, technology services, energy, and financial services with operations in North America, Western Europe, and India. Dr. Bleustein went to CTG from Dell where he had several roles rising to become the Chief Medical Officer and Global Healthcare Solutions Leader with P&L responsibility for Healthcare & Life Sciences Solutions globally.

Doctor Bleustein also had a successful period as a consultant at PwC rising to Director with a diverse experience of projects including interim executive director of outpatient services, business strategy, international “biocluster” development, mergers & acquisitions, healthcare operations, physician alignment, governance, and resource optimization. On the ground experience in the UK, Ireland, India, South Africa, and China with assessments in the Middle East / Asia.

Clifford Bleustein graduated from the Medical College of Wisconsin and completed his internship at the New York Hospital Medical Center of Queens. Cliff later completed his residency in urology at Montefiore Medical Center. Then he went on to private practice Urology and became a board-certified Urologist. He has an extensive roster of peer-reviewed published research and 2 patents. Dr. Bleustein earned a bachelor’s degree in science from the University of Wisconsin, Madison. He also received an executive master’s degree in business administration from NYU Stern School of Business where he now teaches Healthcare Economics as an Adjunct Professor.

Who is Monir El Azzouzi?

He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

Links from the Video

Cliff Bleustein LinkedIn: https://www.linkedin.com/in/cbleustein/
Apos Therapy Website: https://www.apostherapy.com/
Episode 58 – How to register medical devices through 510k: https://podcast.easymedicaldevice.com/58/

The post How to get some help from Medical Device Regulators with Cliff Bleustein appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

How can GDPR impact Medical Devices with Erik Vollebregt

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 14 Sep 2020 00:00:00 +0000

There were a lot of discussions about GDPR since its implementation in early 2018. But after a few years, some issues are happening and this may impact the Medical Device Industry.

The EU MDR 2017/745 articles 109 and 110 + EU IVDR 2017/746 articles 102 and 103 are talking about confidentiality and data protection. This means that medical device manufacturers should also follow GDPR.

Recently there was a judgment (SHREMS II) about data protection with Facebook. And even if Facebook’s act is not specifically related to Medical Devices, this judgment is impacting Medical Device companies.

In this podcast, I have invited our preferred lawyer Erik Vollebregt to help us understand the technical aspect of this judgment and what should Medical Device manufacturers do to continue to stay compliant.

Erik also prepared for you all the documents related to this judgment and the AXON lawyer Newsletter so you have all the details on hand. Download them from the links below.

Who is Erik Vollebregt?

Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish. Chambers Europe 2017: Erik is known for his specialism in regulatory work, which covers medical technology, devices, and products as well as for biotechnology. Clients confirm his strong capabilities, with one saying “he stands out to me. Whenever I work with lawyers he has been the best, with a solid scientific background. He has the perfect combination of skills and experience.”

Who is Monir El Azzouzi?

He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

Links

Erik Vollebregt LinkedIn Profile: https://www.linkedin.com/in/erikvollebregt/
Axon Lawyer website: https://www.axonlawyers.com/
Download documents on SHREMS II: https://mailchi.mp/easymedicaldevice/episode_93
Shrems II judgment blog post: https://medicaldeviceslegal.com/2020/07/23/the-eu-courts-schrems-ii-judgement-urgent-revisiting-of-international-personal-data-transfer-mechanisms-required/
RAPS convergence: Economic Operators Under MDR Tuesday, September 15: https://www.eventscribe.com/2020/RAPS/agenda.asp?pfp=FullSchedule)
MDR/IVDR Implementation, is the glass half full? with Michel Marboeuf and Oliver Bisazza at Advamed Medtech Conference 6 October 15:30 EDT https://medtechvirtual2020.pathable.co/agenda#/?limit=20&searchByComparators[0]=&searchByDisjunctives[0]=false&searchByEncoding[0]&searchByFieldKeys[0]=searchAll&searchByFields[0]=searchAll&searchBySpecial[0]&searchByValues[0]=vollebregt&sortByFields[0]=startsAt&sortByOrders[0]=1
GDPR for MDR application with Jovan Stevovic: https://podcast.easymedicaldevice.com/44/

The post How can GDPR impact Medical Devices with Erik Vollebregt appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Be successful at your MDR and IVDR audit with Martin Witte

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 07 Sep 2020 00:00:00 +0000

If you are preparing for your EU MDR 2017/745 or IVDR 2017/746 audit, then this episode is for you.

I have invited Martin Witte from TÜV SÜD to provide some tips or highlights on what a Notified Body is expecting to see during an audit. Who better than a Notified Body to tell you what you should do.

We will discuss:

Contacting the Notified Body and planning the audit
What is expected to see within your Quality Management System?
How your technical files will be reviewed? – The situation with the Coronavirus and on-site audits

Martin will also be a Speaker at TOPRA Symposium 2020.

Who is Martin Witte?

Martin Witte is Senior Director Strategic Business Development at TÜV SÜD and responsible for the focus topics Active Medical Implants, Cardiovascular, Orthopedic, and Functional Safety/Software.

Prior to his current role, Martin worked as a Lead Auditor, Product Specialist in TÜV SÜD from 2014 on, and took over business development activities with his role as the head of the Active Implants business in 2016. Prior to his roles in TÜV SÜD, Martin was a Regulatory Affairs Manager at BIOTRONIK, Berlin focusing on heart rhythm management devices and on MRI safety of such devices.

His background is Biomedical Engineering which he studied in Hamburg.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.

He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

Medical Device News – August 2020 Review (Monir El Azzouzi)

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 31 Aug 2020 00:00:00 +0000

The Medical Device industry is still moving a few steps forward to EU MDR 2017/745. Here is the agenda of this review:

UDI
Cardiac Implantable Electronic Devices (CIED)
Rolling plan (EUDAMED + Reprocessing of single-use devices)
Green Belt Certificate (New session in French)
Notified Body Situation
New guidance and Standards
Review of the podcast episodes

In this version, the VIDEO PARODY CLIP was blurred as there are some copyrights to the USA.

Who is Monir El Azzouzi?

He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

How to switch quickly to a Virtual Conference with TOPRA

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 24 Aug 2020 00:00:00 +0000

This year is a particular one for the Medical Device Industry and for the world. The pandemic changed completely our way to do things. What was difficult before seems to be the norm now. During the lockdown, a lot of people had to work from home which was something not realistic before. And the healthcare industry was in the front with all the masks, COVID tests… Due to the pandemic, there was also the delay of the EU MDR 2017/745 implementation.

Another thing changed. The way to participate in a conference. And today we will talk with Kevin Pay Chief Executive of TOPRA and Raluca Radu Regulatory intelligence and Symposium Manager. They will share with us about the transition from a face-to-face event to a virtual conference.

When before they had to look for a Hotel Conference room, catering company,… now they should find a good IT company to support a virtual event platform and fix connection bugs… We will see how they’ve tried to help the participant, speakers, and exhibitors to still get most of the experience. This will be really a change in the way to participate in the TOPRA symposium.

If you want to get that experience don’t hesitate to subscribe now on the page link below. Check on the links below the video of last year.

Who is Kevin Pay?

Kevin has worked at director level in both the commercial and charity sectors for the last 15 years, including many years in pharmaceutical packaging (GMP) and at Imperial College Healthcare Charity, before joining TOPRA. Kevin leads the executive team and is accountable for the strategic direction and business plans. He has overall accountability for performance against agreed objectives and risk management across the organization.

Who is Raluca Radu?

Raluca is responsible for ensuring the most relevant topics are covered in TOPRA’s annual meeting plan. She coordinates roundtables, conferences, and the Annual TOPRA Symposium, with a particular focus on programme development, managing the relationship between the working parties, the TOPRA Office, and regulatory authorities. Raluca is a pharmacist by training and has a keen interest in regulatory and health policy, as well as education. Before she joined TOPRA she worked in the Public Engagement and SME Office of the European Medicines Agency.

Who is Monir El Azzouzi?

Link

Kevin Pay LinkedIn: https://www.linkedin.com/in/kevinpay/
Raluca Radu Linkedin: https://www.linkedin.com/in/raluca-radu/
The TOPRA Symposium page: https://www.topra.org/sym2019
Video made at TOPRA Symposium 2019: https://youtu.be/bXAjqj6nikA
TOPRA Symposium 2020 Program for Medical Devices: https://bit.ly/33uiSxN
Podcast Episode 39 – Networking at an event with Lynda Wight: https://podcast.easymedicaldevice.com/39/

The post How to switch quickly to a Virtual Conference with TOPRA appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Best practice for Device Testing with Michael Wetherington

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 17 Aug 2020 00:00:00 +0000

When you are trying to develop a Medical Device, there is a stage that you cannot avoid which is testing your products. For that, I have invited Michael Wetherington from MedicalRegs.com who will help us understand how to prepare for it. We will also help you understand the way you need to follow to choose your Laboratory.

Tests should be done in a lab but also internally. You should test as much as possible to see if you are in the right direction. We will talk a lot about IEC 60601 as an example but other tests can be mentioned.

Michael will also provide information regarding accredited laboratories. This is not really a guarantee of quality and you should be monitoring them. The labs are providing you with a service so don’t just rely on them to perform the right tests as you know the products better than them.

Who is Michael Wetherington?

Who is Monir El Azzouzi?

Best overview of IEC 60601 for Medical Device electrical equipment

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 10 Aug 2020 00:00:00 +0000

In this episode of the Medical Device made Easy Podcast, I have invited Leo Eisner from Eisner Security Consultants to help us understand the standards IEC 60601 series.

Leo is an expert for this standard and in this episode, he will provide you with an overview of what it is and who should use it. As he also helped a lot of companies, he also provides tips about the implementation of this Standard.

Don’t miss also a webinar he recorded with Rob Packard from Medical Device Academy regarding the new addendums to this standard.

Who is Leo Eisner?

Leo Eisner is the Principal Regulatory and Compliance Consultant of Eisner Safety Consultants. Leo’s been involved in IEC 60601 (Medical Electrical Equipment) for 26 years and involved in the development of the IEC 60601 series (on multiple committees, including the interpretations committee) for about 15 years, the CB Scheme ETF-3 Risk Management Group and recently joined the ISO 15223-1 committee. Leo was on an expert panel for the ASCA program on IEC 60601 through the FDA’s CDRH Standards and Conformity Assessment group in May 2018. He’s audited for several EU Notified Bodies and is currently a technical reviewer on Medical Electrical Equipment & an NB auditor for NSAI. Leo started his career at UL back in 1985 and worked in a variety of non-medical areas from alarms, ATMs, HVAC, microwaves, computers, plastics, etc. for 9 years then found medical devices and never turned back.

Who is Monir El Azzouzi?

Medical Device News – July 2020 Update on Quality and Regulatory for Medical Devices

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 03 Aug 2020 00:00:00 +0000

In this monthly episode of the podcast, we talk about all that happened to the Medical Device industry. This is the July 2020 Update.

Within the Hot Topics, we will talk about the UK MHRA which warns about the “Certificate of Compliance” issued by certain certification bodies. We will also review the publication of the EU Commission regarding the PPE conformity assessment. And I will tell you the situation regarding the State of Play for the EU MDR.

Then we’ll review the Green Belt Certification Program. On the next topic, we will explain to you the situation of Notified Bodies. And some clarification on New Guidance and Standards. Don’t miss the clip regarding the Notified Bodies providing Pre-certification to their customers.

Finally, we’ll review what happened at Easy Medical Device these last weeks. Don’t forget to register for the Green Belt Certification Program.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.

He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

Learn UDI code for Medical Devices with Sylvia Reingardt

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 27 Jul 2020 00:00:00 +0000

The UDI code is a new feature introduced by the EU MDR 2017/745 and IVDR 2017/746. It is here to increase traceability and transparency with its combination to the EUDAMED database.

In this Episode, Sylvia Reingardt from GS1 (One of the UDI code Issuing entity) will help us to understand the requirements. She will also share some of the mistakes that she experienced.

Within this episode, Sylvia will also share with us some details about GS1 as a Non-Profit Organization. This organization is also providing training and share with the public a lot of material within its website.

Check links below which contains the pages where all the UDI code information is available. Sylvia shared with us also the emails and phone numbers if you want to call GS1 Germany for more information.

Who is Sylvia Reingardt?

She is a sector manager for Healthcare at GS1 Germany. Prior to joining GS1 Germany in October 2011, she worked for 10 years for a service provider by managing international EDI projects and she was also involved in the development and introduction of new services. Sylvia also spent more than 10 years in the area of procurement at two university hospitals.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.

He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

Links from the Video

Sylvia Reingardt Linkedin Profile: https://www.linkedin.com/in/sylvia-reingardt-3272262b/
GS1 Germany UDI landing page: https://www.gs1-germany.de/gs1-complete/branchenangebote/udi-umsetzung-mit-gs1-standards/
Basic UDI-DI tutorial (german version): https://youtu.be/28N9NZ7UOPY
GS1 Germany – Training (inhouse, online, at GS1 Germany): https://www.gs1-germany.de/no_cache/gs1-academy/weiterbildung/?tx_gs1seminars%5Bcategory%5D%5B80%5D=true#c1397
GS1 Germany Consulting – Email to UDI-Beratung@gs1.de
GS1 Global Office: https://www.gs1.org/industries/healthcare/udi
Medtech Basic UDI-DI guideline: https://www.medtecheurope.org/resource-library/medtech-europes-guidance-on-basic-udi-di-assignment/
Easy Medical Device Article on UDI: https://easymedicaldevice.com/udi
Podcast Episode UDI: https://podcast.easymedicaldevice.com/4/

The post Learn UDI code for Medical Devices with Sylvia Reingardt appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Understand IEC 62304 for Medical Device Software with Adnan Ashfaq

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 20 Jul 2020 00:00:00 +0000

If you are developing Medical Device software then IEC 62304 is an important standard for you. In this episode, Monir El Azzouzi invited Adnan Ashfaq from Pharmi Med Ltd to explain to us what is this standard.

He will also mention some key links to the EU MDR 2017/745 and to other standards. Here are some of the questions asked:

Which medical device companies should use IEC 62304?
Do I need to be a Software developer to be able to work on IEC 62304?
What is the difference between software classification provided by IEC 62304 and EU MDR 2017/745?

Adnan is offering also a document to download which will help you during your projects with this standard.

Who is Adnan Ashfaq?

Adnan Ashfaq is a Quality, Regulatory & Validation Specialist with almost 20 years of experience in Medical Device, Biotech, and Pharmaceutical industries.

Adnan founded Pharmi Med in 2011 and has since been supporting Medical device companies around the labyrinth of regulations and assisting them in flying through successful audits.

He has been working with start-up companies and multinationals in developing new products since 1999. With regulations tightening up, especially in Europe, Pharmi Med is enabling and trying to help simplify the compliance conundrum to ensure manufacturers reach their desired market and stay in the market.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.

He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

How to become a PRRC with TEAM-PRRC (EU MDR & IVDR)

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 13 Jul 2020 00:00:00 +0000

The PRRC is a new role within the EU MDR 2017/745. All medical device companies need a person within their organization to be responsible for that. In this episode, I have invited Team-PRRC which is a non-profit association that is representing the PRRC roles. They are here with me to explain more about it and also explain what are some of the difficulties. Within this session, Elem Ayne (President of Team-PRRC) and Anne Jury (Vice-President of Team-PRRC) accepted to answer my questions and will also share with you what Team-PRRC can do for you.

In this episode, Elem and Ayne will also mention the fees to be part of the association. They have a special offer until May 26th, 2021 which is the date of application of EU MDR.

Who is Elem Ayne?

Elem AYNE is a Quality & Regulatory Affairs Consultant and a member of “DM Experts” network (in France).

She has started her career in R&D in microbiology, oncology, and biochemistry. She obtained 2 degrees in Business Development from 2 different Business Schools, then worked in several fields such as purchasing, supply chain, sales, marketing, quality, and regulatory affairs for different industries, in particular in sterilization.

She has finally specialized herself in Regulatory affairs working especially in Class I reusable granted by a Master’s degree in this field before founding her own company “ACR Medical” to support manufacturers in their compliance with MDR (EU) 2017/745.

She is also the President of the Non-for-profit association Team-PRRC

Who is Anne Jury?

Anne Jury is a consultant in medical device regulatory affairs and quality management systems in the business she founded in 2000.

Before that, she was a lead auditor and area manager working for notified bodies, BSI and then TUV Sud, covering manufacturers large and small in Europe and North America for seven years. Her early career started out with a large medical device technology manufacturer where she was company microbiologist responsible for the release of all sterile devices in the days before CE marking even existed for medical devices.

In her current role, she works mostly with small start-up companies getting new quality systems implemented and developing the regulatory strategy for gaining market access for innovative new devices.

It is in this role that she has realised the potential challenges to be faced by the PRRC in micro and small enterprises and therefore happily accepted the invitation to become the Vice-president of Team-PRRC.

Who is Monir El Azzouzi?

Now, he has created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

Medical Device News – June 2020 Update

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 06 Jul 2020 00:00:00 +0000

In the Medical Device News segment of the podcast, we will talk about what happened during the month of June. Each month we imagine that there is not a lot to say but each month we get some surprises. On the Agenda we have:

The Coronavirus situation for Medical Device Supplies
The MDR IVDR rolling plan. This includes a trailer for a Telenovela
The Green Belt Certification Program
The Notified Bodies Situation
New Standards and MDCG Guidances
What happened at Easy Medical Device

All the links for the sources of the information provided are on the below section

Who is Monir El Azzouzi?

The secrets to being EU MDR certified with Shokoufeh Khodabandeh

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 29 Jun 2020 00:00:00 +0000

We are talking a lot of time about how to be MDR certified and I provide you with some tips etc… In this episode of the Podcast, I wanted to interview someone that succeeded at EU MDR certification so we can get some story and secrets about what went well and what were some of the problems.

Shokoufeh Khodabandeh from Straumann in Switzerland is the EU MDR implementation lead and the team succeeded and received their EU MDR certificate. Shokoufeh will explain to us how they have done:

How long did the project last?
What are some of the issues that happened?
What was the relation with the Notified Body?
How was structured the team?
What are some things that they would have done differently if they should restart?

This will be a really exciting episode as we get behind the curtain of a company that succeeded and they will explain how they have done it. I hope this will be helping other companies.

Who is Shokoufeh Khodabandeh?

Shokoufeh Khodabandeh is the MDR Implementation Lead at Institut Straumann AG, in Switzerland. Shokoufeh holds a Master’s of Science degree from the University of Toronto, and a Post Graduate Degree in Regulatory Affairs and Quality Assurance.

After the early career experience in IVDs and medical devices in the area of Prostate Cancer treatment in Canada, Shokoufeh moved to Switzerland as a Regulatory Affairs and Compliance Manager in the area of Dental Medical Devices, covering EU, USA, and Canadian submissions.

In her current role as the MDR Project Lead, Shokoufeh has spent the past year leading an interdepartmental project to identify the gaps in the existing QMS procedures and product documentation, and planning of the overall implementation strategy.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.

He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

Links from the Video

Shokoufeh LinkedIn Profile: https://www.linkedin.com/in/skhodabandeh/
Blog post Pitfalls on an EU MDR and IVDR project: https://easymedicaldevice.com/pitfalls-mdr-ivdr-projects/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easym edicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post The secrets to being EU MDR certified with Shokoufeh Khodabandeh appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

How to perform your Process Validation with Adnan Ashfaq (IQ OQ PQ)

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 22 Jun 2020 00:00:00 +0000

Process Validation is a science but it needs also some education. In this episode of the Medical Device made Easy Podcast, we will help you understand what is Process Validation.

If you are a Medical Device Manufacturer or if you are an engineer that wants to understand Process Validation, then this episode is for you. We will talk with Adnan Ashfaq from Pharmi Med Ltd. He will share with us his experience and provide some valuable tips to be successful within this process.

Some of the topics we’ll cover are: – FAT SAT IQ OQ PQ – Prospective and retrospective validation – Soft skills to be a good Validation Engineer – What is the most common issue in a validation process? – Validation templates.

Don’t hesitate to contact Adnan Ashfaq to help you with your Validation Process.

He also proposes you to download his “Validation Toolkit”.

Who is Adnan Ashfaq?

Adnan Ashfaq is a Quality, Regulatory & Validation Specialist with almost 20 years of experience in Medical Device, Biotech and Pharmaceutical industries.

Adnan founded Pharmi Med in 2011 and has since been supporting Medical device companies around the labyrinth of regulations and assisting them in flying through successful audits.

He has been working with start up companies and multinationals in developing new products since 1999. With regulations tightening up, especially in Europe, Pharmi Med is enabling and trying to help simplify the compliance conundrum to ensure manufacturers reach their desired market, and stay in the market.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.

He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

How to execute your Internal Audits? (Medical Device companies)

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 15 Jun 2020 00:00:00 +0000

In this episode of the Medical Device made Easy Podcast, Monir El Azzouzi will explain to you how to perform Internal Audits for your company.

Internal Audit is necessary to verify that your Quality Management System is compliant, efficient, and maintained. But how to do that, who can do that, when to do that…? It is also a requirement for ISO 13485, FDA QSR 21 CFR part 820.

And if you need some guidance to implement your Internal Audit process you can also use ISO 19011 to help you. All the answers will be here but remember that the Internal Audit process is also a powerful tool to increase Quality Culture within your organization.

You can use this tool also to convert your departments which are working in Silo to departments that are working together.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.

He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

Medical Device News – May 2020 Review with Monir El Azzouzi

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 08 Jun 2020 00:00:00 +0000

In this episode of the podcast, we will review what happened during the month of May 2020 for the Medical Device Industry. And there was a lot.

The agenda:

EU MDR non-anniversary
The IVDR challenge
The Coronavirus
The Easy Medical Device surprise
Notified Body Situation
MDCG guidance
What happened at Easy Medical Device

You can get all the link of all what we talked about below.

Who is Monir El Azzouzi

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. He has made is study in Biomedical Engineering at the ISIFC school in France which is specialized in all Medical Devices aspects for business. He held a brilliant career within major corporate companies like Johnson & Johnson, BBraun Medical, or Bausch + Lomb.

He always worked within Quality and Regulatory Affairs departments which brings him enough experience to support any organization. For that, he decided to create Easy Medical Device to support Medical Device manufacturers to bring compliant products on the market.

Additionally, his objective is also to help the Medical Device community to learn more about the Medical Device Regulation and Standard, and for that, he creates a blog, a YouTube channel, and a podcast where he educates all his followers.

What means Sufficient Clinical Data with Bassil Akra (EU MDR)

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 01 Jun 2020 00:00:00 +0000

You are maybe trying to build your Clinical Evaluation Report or your PMCF for a Medical Device. And you are stuck because you don’t really understand what means Sufficient Clinical Data?

Then listen to this interview with Bassil Akra from QUNIQUE Group, who is sharing with us his experience as a former TÜV SÜD auditor.

He also participated in the different groups to prepare the guidance that we will discuss today.

During this interview we will discuss:

The difference between MDD 93/42/EC or AIMDD 90/385/EEC and MDR 2017/745 in terms of clinical data
The meaning of Sufficient Clinical Data
The Essential Requirements or General Safety and Performance Requirements for Clinical Data
The Product Equivalence chapter
The PMCF rules
The Expert panel

Bassil Akra will also present to us a Webinar that he will lead to help Medical Device manufacturers deal with the amount of data they should collect to pass an EU MDR audit.

The first session will be on June 8th for the EU time zone and June 11th for the US time zone. Another session will be planned for other timezones.

Who is Bassil Akra?

Dr. Bassil Akra, Co-owner and CEO of QUNIQUE Group has a background in research, development, regulatory approval, and quality management of medical devices.

In addition to his work as a senior field expert for TÜV SÜD, Dr. Akra presents worldwide on the European requirements and was involved in the development of many guidance documents and standards.

In his new role as Co-owner and CEO of QUNIQUE Group, he will now be also able to support Medical Device manufacturers through consulting and training.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.

He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

Don’t hesitate to contact info@easymedicaldevice.com for more information.

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Telegram Channel: https://t.me/easymedicaldevice
Youtube Channel: https://youtube.com/c/EasyMedicalDevice?sub_confirmation=1
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post What means Sufficient Clinical Data with Bassil Akra (EU MDR) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

What is the Notified Body situation? (Bassil Akra from TUV SUD)

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 25 May 2020 00:00:00 +0000

You are looking for a Notified Body for your Medical Device in the EU market but you don’t understand why this is so difficult. In this episode of the Medical Device made Easy podcast, I have invited Dr. Bassil Akra, the VP of Strategic Business Development at TUV SUD. TUV SUD is one of the biggest Notified Body in the World.

Bassil will explain to us the current situation with Notified Bodies while we have a pandemic where Notified Bodies cannot perform on-site audits but also while we have a 1-year delay for the EU MDR application. So we hope that this episode will answer all your questions and that you will understand why getting an MDD 93/42/EC or AIMDD 90/385/EEC certification is something that is not easy anymore. You will understand also why during the next months you will not be able to issue a new certificate for a new Medical Device.

We will also talk about the “Devil” regulation which is renewing the accreditation of Notified Bodies without following the normal route. And you will understand why it is called the Devil regulation.

In the end, Bassil will also explain to you how it is to work at a Notified Body and all the benefits that you can get. Don’t forget to check the links below for more help.

Who is Dr. Bassil Akra?

Dr. Bassil Akra, Vice President of Global Strategic Business Development for TÜV SÜD Product Service has a background in research, development, regulatory approval, and quality management of medical devices.

Dr. Akra is a member of various Medical Device Regulation (MDR) European task forces, to help with the interpretation of the new legislation towards a smooth transition into May of 2020. In addition to his work as a senior field expert.

Dr. Akra presents worldwide on European requirements and is involved in the development of many guidance documents and standards.

Who is Monir El Azzouzi?

He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

For any Quality or Regulatory Affairs projects, please contact us through the EasyMedicalDevice.com website.

How to get ISO 13485 certified? (Quality Management System)

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 18 May 2020 00:00:00 +0000

In this episode of the Medical Device made Easy Podcast, I wanted to answer a recurring question I receive with as much detail as possible. The question is: “How to get ISO 13485 certified?”

As Easy Medical Device is a consulting agency helping Medical Device manufacturers to place compliant medical devices on the market, most of our clients have no experience in the Medical Device Regulations.

So in this video, I will answer this question.

AGENDA

What is ISO 13485?
Who can provide this certificate?
How much does it cost to get ISO 13485 certified?
Frequency of the audits
What contains ISO 13485?
ISO 13485 certified versus US FDA 21 CFR part 820
ISO 13485 within the MDSAP program
Easy Medical Device support

Don’t hesitate to reach Easy Medical Device to get some support on your QMS certification process. Or any other Quality and/or Regulatory affairs question.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.

After working for many years with big Healthcare company and particularly Johnson and Johnson, Bausch and Lomb or BBraun Medical, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world.

He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

Links for ISO 13485

5 Steps to create a Quality Management System: https://easymedicaldevice.com/5-steps-quality-management-system/
How to verify a certification body?: https://easymedicaldevice.com/accreditation-certification-body/
Best Tips: ISO 13485 procedures with our free template: https://easymedicaldevice.com/iso-13485-procedure/
ISO standard: https://iso.org
Harmonized Standard MDD 93/42/EC: https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en
Harmonized Standard AIMDD 90/385/EEC: https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/implantable-medical-devices_en
Harmonized Standard IVDD 98/79/EC: https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/iv-diagnostic-medical-devices_fr
QMS for economic Operators: https://easymedicaldevice.com/economic-operators/
How to prepare for an Audit article: https://easymedicaldevice.com/medical-device-audit/
Episode 10 – What is MDSAP?: https://podcast.easymedicaldevice.com/10/
MDSAP article: https://easymedicaldevice.com/mdsap/
FAQ article: https://easymedicaldevice.com/faq-iso-13485/

The post How to get ISO 13485 certified? (Quality Management System) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

How to get your Digital Health Application reimbursed in Germany? (DIGA)

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 11 May 2020 00:00:00 +0000

In Germany, a new law was issued for Digital Health Application. To help us understand the content of this law, I have asked Stefan Bolleininger who is helping companies to send an application for it. The name of this application is called DIGA. The acronym will be explained to you in this episode. And we will also explain which app is in and out of scope. What is important to understand if the fact that this law requires you first to be a medical device and then to have your CE mark for it before to get approved for DIGA.

Who is Stefan Bolleininger?

Who is Monir El Azzouzi?

Links from the Video

Stefan’s LinkedIn Profile: https://www.linkedin.com/in/stefan-bolleininger-3a717028/
Be-on-Quality website: http://www.be-on-quality.com/
The german law http://www.bgbl.de/xaver/bgbl/start.xav?startbk=Bundesanzeiger_BGBl&jumpTo=bgbl120s0768.pdf
The German Institute https://www.bfarm.de/DE/Medizinprodukte/DVG/_node.html
The DIGA guidance: https://www.bfarm.de/SharedDocs/Downloads/DE/Service/Beratungsverfahren/DiGA-Leitfaden.pdf;jsessionid=E7B0133B29FAF6555378DC6063271D7E.1_cid507?__blob=publicationFile&v=2

The post How to get your Digital Health Application reimbursed in Germany? (DIGA) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Medical Device News – April 2020 Regulatory Update

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 04 May 2020 00:00:00 +0000

In this episode of the Medical Device made Easy Podcast, we will review;

How Coronavirus is shaking the Medical Device World?
The Notified Body Situation
The Anniversary of the Mini-Course MDR 2017/745
New MDCG guidance released in April 2020
All the events that happened at Easy Medical Device Check the links section to find all the sources for the information provided.

Who is Monir El Azzouzi?

How to calculate your sample size with Jon Bergsteinsson

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 27 Apr 2020 00:00:00 +0000

When you are starting a study like a Clinical Trial or Clinical Investigation or PMCF, you arrive at a point where you need to define how many people need to be included. This is the sample size. In this episode, we will help you to calculate your sample size. My guest is Jon Bergsteinsson VP at Smart-trial. He will present to us the way a sample size needs to be considered so your project is successful. To help you with sample sizing, Jon is also offering an eBook so you can get all the information needed to perform that by yourself. So don’t forget to download it. –

Who is Jon Bergsteinsson?

About SMART-TRIAL

SMART-TRIAL offers a do-it-yourself Electronic Data Capture for clinical investigations and PMCF activities, including registries and surveys. Built to empower MedTech clinical teams to be their best, and in full control of their data, without compromising on features, design, or compliance.

Who is Monir El Azzouzi?

Links from the Video

Jon’s LinkedIn Profile: https://www.linkedin.com/in/joningib/
Smart-trial presentation: https://www.youtube.com/watch?v=lJTGnuAJ2Ng
Link to download the Medical Device Sample Size Cookbook: https://info.smart-trial.co/ebook/medical-device-sample-size-cookbook
Link to watch the webinar on how to estimate sample size for medical device studies: https://info.smart-trial.co/webinar/how-to-estimate-sample-size-for-medical-device-studies
Other white papers and webinars for MedTech professionals: https://info.smart-trial.co/resource/content-curated-for-the-medtech-industry

The post How to calculate your sample size with Jon Bergsteinsson appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

The 1-year delay for the EU MDR 2017/745 with Erik Vollebregt

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 20 Apr 2020 00:00:00 +0000

This week I had some exciting moment when I followed the EU parlement webcast on the April 17th, plenary session to see what they will decide about the proposal to delay the EU MDR until May 26th, 2021.

Already in the morning we had a first vote with some good result. And at the end of the day it was confirmed. The EU parliament adopted the proposal.

Now in this episode we will come back on the context and the consequences of this vote for the Medical Device Industry.

Erik Vollebregt and I followed these last weeks the situation and want now to provide you some answers as I get a lot of questions.

Some of the topics that we will discuss are the consequence to:

EUDAMED
Article 59 of the EU MDR and 54 of the EU IVDR
Notified Body situation
Brexit, Swixit and Turxit
Economic Operators
Annex XVI

Who is Erik Vollebregt?

He actively contributes to law and policy development at the national and EU levels via membership of specialized committees at branch associations and the European Commission.

Who is Monir El Azzouzi

He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

Link

Erik Vollebregt Linkedin profile: https://www.linkedin.com/in/erikvollebregt/
Axon Lawyers website: https://axonlawyers.com
Erik’s blog post on the parliament vote: MDR date of application move: politically a done deal now
Proposal adopted document: https://www.europarl.europa.eu/doceo/document/TA-9-2020-0053_EN.pdf
Council secretariat information note: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CONSIL:ST_7322_2020_INIT&from=EN
A general overview of procedure for the amendment: https://eur-lex.europa.eu/legal-content/EN/HIS/?uri=COM:2020:144:FIN
Parliament decides to postpone new requirements for Medical Devices: https://www.europarl.europa.eu/news/en/press-room/20200415IPR77113/parliament-decides-to-postpone-new-requirements-for-medical-devices
Blog post: MDR amendment proposal Article 120(3) oversight set to be fixed by Council: https://medicaldeviceslegal.com/2020/04/08/mdr-amendment-proposal-article-120-3-oversight-set-to-be-fixed-by-council/
Blog post: The MDR amendment proposal: more than meets the eye: https://medicaldeviceslegal.com/2020/04/04/the-mdr-amendment-proposal-more-than-meets-the-eye/
Blog post- Commission working on a proposal to postpone MDR date of application for one year: https://medicaldeviceslegal.com/2020/03/25/commission-working-on-proposal-to-postpone-mdr-date-of-application-for-one-year/

The post The 1-year delay for the EU MDR 2017/745 with Erik Vollebregt appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Medical Device School – Why are Staff hiding problems to QA & RA?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Wed, 15 Apr 2020 00:00:00 +0000

If you are working for Quality then you maybe experienced this situation. And if you are an employee outside of Quality then we maybe understand why you are doing that.

Monir El Azzouzi and Karandeep Badwal are discussing their experience when it is about hiding problems to the Quality Departments. They will also define the consequences of that and how this can change.

Who is Karandeep Badwal?

Mr. Karandeep Singh Badwal is a Regulatory and Quality Contractor specializing in medical devices, his educational background is an MSc Pharmaceutical Quality by Design, however, has worked almost exclusively within the medical devices industry from multinational companies to startups since his graduation.

Who is Monir El Azzouzi?

Link

Karandeep Badwal LinkedIn Profile: https://www.linkedin.com/in/karandeepbadwal/
What is Quality for Monir El Azzouzi? : https://easymedicaldevice.com/what-is-quality/

The post Medical Device School – Why are Staff hiding problems to QA & RA? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

MDR & Drug-Device Combination Products with Theresa Jeary

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 13 Apr 2020 00:00:00 +0000

This episode will be really interesting for the pharmaceutical companies that are producing Drug-Device combination products as it explains the consequence of EU MDR Article 117 for their products.

For all projects that are ongoing, you need to consider the new requirements coming from EU MDR as this is amending the 2001/83/EC Medicinal Product Directive.

Theresa Jeary will be my guest during this episode, and her experience with Drug-Device products and as a former Notified Body assessor will help you understand what are the deliverables you should provide now.

We will also discuss the importance of the Notified Bodies during this process as the pharma industry is not really used to deal with this kind of third party entity.

Finally, Theresa prepared a document that you can download below. It will provide you with a summary of the situation for Drug-Device combination products when it comes to the EU MDR.

Who is Theresa Jeary?

Theresa has over 30 years’ experience working in both the Pharmaceutical and Medical Device industries and has been involved in the development of many commercially available medicinal and medical device products.

Theresa has over 12 years of Notified Body experience, initially at BSI as a technical expert for devices with ancillary medicinal substance and she held the position of Head of Notified Body at the UK NB LRQA until January 2019.

Her core area of technical expertise is in the combination product area and Theresa now works as a consultant to the Pharmaceutical and Medical device sectors supporting Companies in meeting regulatory requirements. Theresa is a frequently invited speaker on the medical device legislation and combination products.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.

He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

Medical Device News – March 2020 Review (EU MDR)

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 06 Apr 2020 00:00:00 +0000

In this episode of the Podcast, I will provide you with the situation for the month of march 2020 and what should happen next.

As you may know we are in the beginning of a pandemic and this is really a stressful situation for all countries worldwide. So this episode will also show you some elements that should be interesting for you to know during this period.

We will also discuss about the Notified Body Situation. There is a new Notified Body that was announced but this is not enough. We need more. Let’s see the numbers.

I will also list the MDCG guidances and regulatory updates that were released.

Finally, we will review what happened at Easy Medical Device during that month.

Don’t miss the links with all the source of information

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.

He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

Links from the Video

Coronavirus
- DoA delay 1 year: https://audiovisual.ec.europa.eu/en/video/I-187348
- Proposal for extension of MDR DoA to + 1 year: https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1585914772359&uri=COM:2020:144:FIN
- Erik Vollebregt Blog Post: https://medicaldeviceslegal.com/2020/04/04/the-mdr-amendment-proposal-more-than-meets-the-eye/
- Notified Body audits suspended: https://www.dakks.de/en/content/dakks-adopts-safety-measures-suspension-site-assessments
- Coronavirus impact on the Medical Device Industry: Medical Device Industry impact due to Coronavirus Outbreak (EU MDR): https://youtu.be/_m3egM0HEns
- MHRA guidance: https://www.gov.uk/guidance/mhra-regulatory-flexibilities-resulting-from-coronavirus-covid-19
- Free Standards available for Covid19 products: https://www.cencenelec.eu/News/Press_Releases/Pages/PR-2020-003.aspx
Notified Body Situation
- State of play March 2020: https://ec.europa.eu/docsroom/documents/40341?locale=en
- MDR 2017/745 NB: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34
- IVDR 2017/746 NB: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=35
Regulatory Updates
- Harmonized Standard update for MDD 2020/437: https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1585235207379&uri=CELEX:32020D0437
- Harmonized Standard update for AIMDD 2020/438: https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1585235819491&uri=CELEX:32020D0438
- Harmonized Standard update for IVDD 2020/439: https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1585235896183&uri=CELEX:32020D0439
- MDCG Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software 2020-1: https://ec.europa.eu/docsroom/documents/40323?locale=en
- MDCG Guidance Class Transitional Provision under Article 120(3 and 4) 2020-2: https://ec.europa.eu/docsroom/documents/40324?locale=en
- MDCG Guidance Significant Change 2020-3: https://ec.europa.eu/docsroom/documents/40301/attachments/1/translations/en/renditions/native
Easy Medical Device podcasts
- Episode 67 – Cybersecurity with Erik Vollebregt: https://podcast.easymedicaldevice.com/67/
- Episode 68 – Class Is, Im and Ir with Elem Ayne: https://podcast.easymedicaldevice.com/68/
- Episode 69 – Significant Changes with Erik Vollebregt: https://podcast.easymedicaldevice.com/69/
LinkedIn Live
- How to classify a Medical Device: How to classify a Medical Device? (EU MDR Case Studies): https://youtu.be/JXuLft-IEZg
- FAQ on Economic Operators with Erik Vollebregt: FAQ Medical Device Economic Operators? (EU MDR and IVDR): https://youtu.be/qvOyEofrhgk
- Coronavirus outbreak with Erik Vollebregt, Bassil Akra, and Gert Bos: Medical Device Industry impact due to Coronavirus Outbreak (EU MDR): https://youtu.be/_m3egM0HEns

The post Medical Device News – March 2020 Review (EU MDR) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

What is a Significant Change for your Medical Device? with Erik Vollebregt

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 30 Mar 2020 00:00:00 +0000

This is a topic that all of you are talking about. What is a Significant Change to your Medical Device?

I may say, it depends and this is also the answer of Erik Vollebregt who is my guest in this episode of the Podcast.

He will help us understand what you should consider a Significant Change and also provide some examples like for Software companies or also for a change of suppliers or finally during a Merger and Acquisition.

Why is this is so important? Because this would have an impact on your transition period. If you have an MDD certificate that expires after May 26, 2020, then you can benefit from a transition period where you can still supply your medical devices even if they have not transitioned to EU MDR.

But if your device is having a Significant Change during this period, then the transition period stops for it. It immediately falls under EU MDR. So it is important for Medical Device Manufacturers to understand this concept and plan a strategy for it.

After the recording of this episode, the MDCG finally released the guidance expected. I put the link below. This is based on some documents that we discussed during this episode. All that was covered in this episode is not changed due to this guidance.

Who is Erik Vollebregt?

He actively contributes to law and policy development at the national and EU levels via membership of specialized committees at branch associations and the European Commission.

Who is Monir El Azzouzi?

He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

All about Class Is, Im and Ir with Elem Ayne (EU MDR 2017/745)

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 23 Mar 2020 00:00:00 +0000

We already talked on the podcast about the class I devices. But here I wanted to focus more on the sub-classes of class I products. There are 3 sub-classes which are Class I sterile (Is), Class I with a measuring function (Im) and the new Class I for surgical reusable devices (Ir). When class I products are Self-Certified, you should know that this is not the case for class I special devices.

Elem Ayne from ACR Medical will help us understand the difference and what should be done to have compliant medical devices. She will also tell you what will be checked during an audit. This part is really important. Don’t forget also to download the presentation that Elem prepared for you.

Who is Elem Ayne?

Elem AYNE is a Quality & Regulatory Affairs Consultant and a member of “DM Experts” network (in France). She has started her career in R&D in microbiology, oncology, and biochemistry.

She obtained 2 degrees in Business Development from 2 different Business Schools, then worked in several fields such as purchasing, supply chain, sales, marketing, quality and regulatory affairs for different industries, in particular in sterilization.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.

He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

Links from the Video

Elem Ayne LinkedIn profile: https://www.linkedin.com/in/elemayne/
Presentation to download: https://mailchi.mp/easymedicaldevice/class_i_special

The post All about Class Is, Im and Ir with Elem Ayne (EU MDR 2017/745) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Cybersecurity for your Medical Devices with Erik Vollebregt

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 16 Mar 2020 00:00:00 +0000

Let’s see if what is shown in movies is correct. Can some hackers take control of a Hospital or kill you by hacking an insulin pump. Is this science fiction or reality. In this episode of the Medical Device made Easy Podcast, we will focus on cybersecurity for Medical Devices.

The new Medical Device Regulation is providing more information on Softwares and this is due to the progress done which can then lead to some issues. Erik Vollebregt will be my guest on the podcast to explain to us:

What manufacturers should do to comply with the regulations?
Which guidance they should follow?
Is it the same in all the countries?

Don’t forget to look at the links with all the guidance that we discussed today.

Who is Erik Vollebregt?

He actively contributes to law and policy development at the national and EU levels via membership of specialized committees at branch associations and the European Commission.

Who is Monir El Azzouzi?

He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

Medical Device Regulatory Update – February 2020

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 09 Mar 2020 00:00:00 +0000

On this Regulatory Update, we will talk about many diverse topics but here is an outline.

First, we will review the Coronavirus situation and I will also provide you with some fun facts that are happening.

Then we will talk about MDCG committee. We’ll review the guidance issued and the topics they will discuss during this march meeting.

After that, we will discuss the Notified Body Situation. How many are available? Who are the new ones?

Finally, we’ll review some US guidance that are issued and even a Ban of a certain device.

I will also take the opportunity of this review to review all the topics that were discussed on the podcast, and also the LinkedIn Live.

I really hope this will be informative to you.

Who is Monir El Azzouzi

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.

He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

Do your Economic Operators need a Quality Management System?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Wed, 04 Mar 2020 00:00:32 +0000

We know that the Manufacturer of a Medical Device needs a Quality Management System, but what about the Importer, Distributor or Authorized Representative? Do they also need to show they have a system that guarantees that what they are distributing is correct? Erik Vollebregt from Axon Lawyers will help us understand what is written on the different texts. The answer is not easy as there is what is mandatory by EU MDR 2017/745 or EU IVDR 2017/746 and what is common sense. Can you be blamed because you don’t have an ISO 13485 certification? Don’t forget to review the other episodes related to Economic Operators to have a full view of the process.

Who is Erik Vollebregt?

He actively contributes to law and policy development at the national and EU levels via membership of specialized committees at branch associations and the European Commission. Erik also works as an arbitrator in medical devices related disputes and is regularly retained as an expert witness in foreign litigation.

Who is Monir El Azzouzi?

Links from the Video

Erik Vollebregt Linkedin: https://www.linkedin.com/in/erikvollebregt/
Axon Lawyer website: https://www.axonlawyers.com/
Bonus Episode 9 – What is the responsibility of Economic Operators: https://podcast.easymedicaldevice.com/mds9/
HPRA Distributor Guidance: https://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/ia-g0004-guide-for-distributors-of-medical-devices-v1.pdf?sfvrsn=13

The post Do your Economic Operators need a Quality Management System? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Create your intended purpose with Cesare Magri (Medical Device)

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 02 Mar 2020 00:00:00 +0000

As Cesare Magri said, the intended purpose is not really a priority for some companies so they don’t take to much time to write them. But you will hear in this episode why it is clearly a strategic task for your company.

When you are creating your EU MDR 2017/745 technical documentation, you have to also define some scope for your product. And it is the objective of the intended purpose.

Cesare Magri from be-on-Clinical (which is related to be-on-Quality) is helping companies and he sees a lot of examples of issues related to the intended purpose. He will share with us the different steps needed to build your intended purpose and he will offer also a document to download that can be used to brainstorm regarding your intended purpose with your team.

Who is Cesare Magri?

Cesare has a mixed Background: Physics and Neuroscience, PhD in Informatics. He worked as a biostatistician at Max Planck in Tübingen and started working with medical devices and clinical evaluations in 2013. Recently he founded be-on-Clinical together with Stefan Bolleininger in 2020.

Who is Monir El Azzouzi?

Medical Device School: What should verify your Economic Operators?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Wed, 26 Feb 2020 00:00:00 +0000

We continue on this series about Economic Operators and this time we will let you understand what they should check. What an Importer, Distributor or Authorized Representative should check before placing your product on the market.

Erik Vollebregt from Axon Lawyers will help us to interpret the regulation as many peoples are asking some questions regarding sampling checks or about the level of details to review some elements. So don’t miss this series which will provide you with all the details.

Don’t hesitate also to go to the link section to check the Agreement Templates that I created on Economic Operators. They were reviewed specifically to match the MDR and IVDR requirements.

Who is Erik Vollebregt?

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.

He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

Links from the Video

Erik Vollebregt LinkedIn: https://www.linkedin.com/in/erikvollebregt/
Erik Vollebregt Presentation: https://www.slideshare.net/ErikVollebregt/managing-new-requirement-for-economic-operator-regime
HPRA – Guide for Distributors of Medical Devices: https://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/ia-g0004-guide-for-distributors-of-medical-devices-v1.pdf?sfvrsn=13
Easy Medical Device Shop (Download Economic Operators Agreement Templates): https://easymedicaldevice.com/shop/
RAPS Focus. Economic Operators: Roles and Obligations under EU’s MDR: https://www.raps.org/news-and-articles/news-articles/2020/2/economic-operators-roles-and-obligations-under-eu
Medtech Europe Flowchart MDR: https://www.medtecheurope.org/wp-content/uploads/2018/01/EN_MTE_MDR_Flowchart_Dec2017.pdf

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Medical Device School: What should verify your Economic Operators? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Clinical Data for Low Risk Medical Devices with Robert van Boxtel

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 24 Feb 2020 00:00:00 +0000

We talked a lot about how to perform a Clinical Evaluation for your medical device. But when your device has a low risk and there is not enough data to prove safety, how then it is possible to show that you have enough data to place your device on the market. Robert van Boxtel from MD Project will help us define what can be done as there is always a solution. Robert will help you with some suggestions on how you can collect data that you already have as preclinical data or will help you find some information regarding other devices. What is also interesting is to talk about clinical data with products that are not touching the patients at all. We will also clarify that. Don’t forget to download the presentation that Robert prepared about this topic.

Who is Robert van Boxtel?

Robert van Boxtel graduated in the field of biomedical materials from the University of Twente in the Netherlands (MSc).

For eight years he worked in the medical device industry in the Netherlands and USA, in different roles within R&D and manufacturing. In 2003 he started at Notified Body KEMA Quality B.V., currently known as Dekra Certification. In his job as Sr. Project Manager Certification Medical Devices, Robert van Boxtel worked around the globe to assess medical devices on safety and performance, and audit the QMS’s of medical device manufacturers.

As a result, he developed an in-depth knowledge of CE regulations and ISO 13485. In addition to that, he was responsible for international large accounts and the FDA 3rd party review program, in which KEMA (Dekra) was participating at the time. During the last 9 years, as Principal Consultant at Medical Device Project B.V. in the Netherlands, he is assisting medical device manufacturers with their QMS, technical files, and regulatory submissions.

In addition to that, he is hired by the Dutch Norm Institute (Royal NEN), as SME for teaching on ISO 13485 and MDD/MDR. Furthermore, he participates in TC210 discussions on risk management, ISO 13485 and PMS. As a result, he has 25 years of experience in the medical device industry.

His expertise’s are:

EU medical device regulations (MDR/IVDR)
ISO 13485:2016
Risk management (including animal tissue)
Clinical evaluation;
PMS;
QMS development/improvement;
Troubleshooting; Product-, equipment- and process validation;
Participating in / leading development projects;
Building Regulatory submission files (EU and USA);
Lead Auditor.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.

He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

Medical Device School – Who controls your Economic Operators?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Wed, 19 Feb 2020 00:00:00 +0000

In this Medical Device School Bonus episode, Erik Vollebregt and Monir El Azzouzi are helping you to understand the way the Economic Operators are controlled.

A Manufacturer can be controlled for example by a Notified Body. But what about a Distributor, Importer or Authorized Representative? You’ll know everything about it in less than 10 minutes.

Economic Operators need to create agreements between them to be sure that they are working in collaboration. Check the templates provided in the shop. They were updated to meet the EU MDR and IVDR requirements.

Who is Erik Vollebregt

He actively contributes to law and policy development at the national and EU levels via membership of specialized committees at branch associations and the European Commission.

Erik also works as an arbitrator in medical devices related disputes and is regularly retained as an expert witness in foreign litigation. Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish. Chambers Europe 2017: Erik is known for his specialism in regulatory work, which covers medical technology, devices, and products as well as for biotechnology.

Who is Monir El Azzouzi

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.

He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

Link

Monir El Azzouzi LinkedIn: https://www.linkedin.com/in/melazzouzi/
Erik Vollebregt LinkedIn: https://www.linkedin.com/in/erikvollebregt/
Erik Vollebregt Presentation: https://www.slideshare.net/ErikVollebregt/managing-new-requirement-for-economic-operator-regime
HPRA – Guide for Distributors of Medical Devices: https://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/ia-g0004-guide-for-distributors-of-medical-devices-v1.pdf?sfvrsn=13
Easy Medical Device Shop (Download Economic Operators Agreement Templates): https://easymedicaldevice.com/shop/

The post Medical Device School – Who controls your Economic Operators? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Are Brexit, Swixit, and Turkxit a reality? with Erik Vollebregt

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 17 Feb 2020 00:00:00 +0000

Alert: Too much -xit will be mentioned in this episode of the Podcast. We apologize if some confusion happens.

Monir El Azzouzi and Erik Vollebregt will help you understand the situation in the United Kingdom with Brexit, talk a bit of the Switzerland situation or Swixit and then finish with the situation in Turkey called Turkxit.

Brexit: Since February 1st, 2020 Brexit is live. So what are the consequences for the medical device manufacturers? What should they do now?

Swixit: We discussed during the last episode about Swixit with Ronald Boumans. Erik did talk about it to compare its situation to Brexit or other countries.

Turkxit: Turkey does have the same situation as Switzerland now. But the process seems less transparent. If some people can give us some feedback it would be great.

We hope that there will be no other XIT that will happen as we are stronger together.

Who is Erik Vollebregt

He actively contributes to law and policy development at the national and EU levels via membership of specialized committees at branch associations and the European Commission.

Who is Monir El Azzouzi

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.

He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

Medical Device School – Who are your Economic Operators?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Wed, 12 Feb 2020 00:00:00 +0000

With MDR 2017/745 and IVDR 2017/746, we discover some new Vocabulary and one of them is clearly important to consider and this is “Economic Operators”.

Monir El Azzouzi and Erik Vollebregt will help you define who are your Economic Operators and also if you are still not sure, how to identify them.

Don’t forget to download the presentations and documents provided in the link section.

Who is Erik Vollebregt?

He actively contributes to law and policy development at the national and EU levels via membership of specialized committees at branch associations and the European Commission.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.

He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

Swixit or not Swixit? this is the question with Ronald Boumans

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 10 Feb 2020 00:00:00 +0000

We started to talk a lot about Brexit, but in the meantime for the Medical Device Industry, Swixit is starting to happen.

This is for Switzerland Exist from the European Union. But here we are not talking about the same exit as for the UK. Here we are talking only about the Medical Device industry.

Learn more in this episode of the Medical Device made Easy Podcast with Ronald Boumans from Emergo. He will explain to us what is happening to the Swiss market and what can be done to be ready.

Who is Ronald Boumans?

Ronald Boumans started his career as an industrial designer working in R&D designing smart packaging concepts. He has also had his own company importing medical devices from the far east into The Netherlands.

After that failed he worked for an organization researching the relation between quality of life and the use of medical devices. This brought him to a certification organization (TNO).

After that, he worked as a senior Inspector for medical technology for the Dutch Competent Authority. In 2013 he started working for Emergo as a senior consultant where he is now specializing in the European legislation and the political developments (e.g. Switzerland, Brexit).

He is also a board member of the European Association of Authorized Representatives (EAAR) which he represents at the European Commission in several Eudamed and UDI working groups.

Medical Device School – Process Validation or Verification?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Wed, 05 Feb 2020 00:00:00 +0000

When you need to prove that your product conforms to the Specification, Process Validation or Verification is a good question you should ask yourself.

Monir El Azzouzi and Stefan Bolleininger will guide you so you can decide if you should perform validation or verification.

We will also present you with some tools and tricks to find some answers to your questions.

Who is Monir El Azzouzi

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.

He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

Who is Stefan Bolleininger

Stefan Bolleininger is a key opinion leader and speaker for the medical device regulation MDR in Europe.

Episode 61 – Medical Device Regulatory Update: January 2020

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 03 Feb 2020 00:00:00 +0000

In this episode of the Medical Device made Easy Podcast, we will review all the major updates that happened in the Medical Device world.

I will try to gather the most important information and comment on them for you. This will also provide you the details of what happened on Easy Medical Device.

During this review, we will discuss the Guidances, standards, regulations that were released. We will also talk about the important news announced like Brexit or Switzerland MRA situation.

In the link section, I tried to gather all the sources for the information I provided so you can check that directly.

I am planning some LinkedIn Live. Don’t forget to follow me on LinkedIn (https://linkedin.com/in/melazzouzi) to be able to see when I am going live. I will also provide you the information when this will be planned. Usually on Friday at 3 pm CET.

How to register your Device in Brazil with Tania Aprigliano? (ANVISA)

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 27 Jan 2020 00:00:00 +0000

Are you considering Brazil as a country to register and distribute your Medical Devices? In this episode, we will give you all the information you need to make it easy for you and grow your business in this country.

Tania Aprigliano, will be my guest on this episode of the Medical Device made Easy Podcast and she will help us define what are the key steps you need to follow so ANVISA (Brazilian Agency) will authorize you to import your products to Brazil.

We will also discuss the advantage that you would have if you apply for MDSAP which means “Medical Device Single Audit Program”. This is a program that helps you to get certified to sell your products in 5 countries (USA, Brazil, Canada, Japan, Australia).

Who is Tania Aprigliano?

Professional with over 10 years of experience in product research and development, project management, technical documentation elaboration, and quality system implementation.

Acting in large multinational companies, in diversified segments as chemicals and medical devices.

Why is it Awesome to work in a Quality or Regulatory affairs job?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Wed, 22 Jan 2020 00:00:00 +0000

In this bonus episode of the Medical Device School, I asked Karandeep Badwal to tell us why a Quality and Regulatory Job in the medical device industry is awesome.

I know it’s not obvious but let’s see what Karandeep has as arguments. QA and RA do have bad press as these departments are considered to block projects or other things but maybe if you use another pair of glasses you will see the situation all other ways around.

If you are interested to know more about a Quality or Regulatory Affairs job, don’t hesitate to contact us.

Who is Karandeep Badwal?

Mr. Karandeep Singh Badwal is a Regulatory and Quality Professional specializing in medical devices.

His educational background is an MSc Pharmaceutical Quality by Design, however, he has worked almost exclusively within the medical devices industry from multinational companies to startups since his graduation.

How to create a QMS compliant to MDR with Stefan Bolleininger

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 20 Jan 2020 00:00:00 +0000

In this episode of the Medical Device made Easy Podcast, Monir El Azzouzi, and Stefan Bolleininger are helping you to create your quality management system with the objective to be compliant to EU MDR 2017/745 or EU IVDR 2017/746 Now even class I devices should have a Quality Management System, but:

Should you apply to ISO 13485?
Is it mandatory?
Do you need to contact a Notified Body or are there other options?

We will help you by providing a step by step understanding on how to get a Quality Management System. We will also help you understand the audit process.

Who is Stefan Bolleininger ?

This support covers the full chain of quality and regulatory requirements: Implementation, maintenance, audits, assessments, and inspections. In the area of “Risk Management and Usability for Medical Devices and Medical Networks”, he holds a teaching assignment at the Technical University of Nuremberg and the VDI Technical Committee “Quality Assurance for Software in Medical Devices”.

How to register your Medical Device through 510k with Michelle Lott

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 13 Jan 2020 00:00:00 +0000

Subscribe

510k is a famous way to register your Medical Devices in the US. It is so famous that even if you don’t need it, you will ask to go through it. In this episode, Michelle Lott, Founder, and Principal at LeanRAQA will help us understand everything about 510k. And she is also providing a Slide deck to help you understand all about the FDA process.

We will discuss the different types that are existing:

Traditional
Abbreviated
Special

We will also discuss the way to use standards to confirm that your product conforms to the regulation. Similar to the Harmonized Standards used in Europe.

On a different note, Michelle will explain to the audience participation in the MDG Premium. This is a group where Medical Device experts, manufacturers, service providers are part of.

Who is Michelle Lott

She has served on the FDA Device Good Manufacturing Practices Advisory Committee and is a vocal advocate of EU MDR readiness. Michelle serves the medical device, dietary supplements, biologics, pharmaceutical, cosmetics, and food industries.

She has a weakness for tequila and anything barbecued.

Links for this episode

Michelle Lott Linkedin: https://www.linkedin.com/in/michellelottraqa/
LeanRAQA website: https://leanraqa.com/
Download 510k Presentation: https://mailchi.mp/easymedicaldevice/510k-presentation
MDG Premium website: https://www.medicaldevicesgroup.net/premium/
FDA 510k process: https://www.fda.gov/medical-devices/premarket-notification-510k/510k-forms
Substantial equivalence blog post: https://easymedicaldevice.com/substantial-equivalence-on-a-fda-510k-process-how-to-demonstrate-it/
Episode 43 – FDA Registration: https://podcast.easymedicaldevice.com/43/

The post How to register your Medical Device through 510k with Michelle Lott appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Medical Device School: How to audit your Suppliers?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Wed, 08 Jan 2020 00:00:00 +0000

A supplier audit is a difficult task that really needs to be well understood. With the new Medical Device Regulation EU MDR 2017/745, there is a specific requirement that Medical Device Manufacturers should have better control of their suppliers.

I always hear that as soon as the supplier is ISO 13485 it is sufficient for the manufacturers, but this is not really answering the question if your product is manufacturers following your specification…

So I propose to more focus on product specification instead of ISO 13485 requirements. Check the discussion I have with Stefan Bolleininger from Be-on-Quality

Who is Stefan Bolleininger?

Who is Monir El Azzouzi?

Links from the Video

Stefan Bolleininger LinkedIn: https://www.linkedin.com/in/stefan-bolleininger-3a717028/
Using audits to improve supplier performance: https://www.mddionline.com/using-audits-improve-supplier-performance

The post Medical Device School: How to audit your Suppliers? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Post-Marketing Clinical Follow-up with Helene Quie (PMCF)

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 06 Jan 2020 00:00:00 +0000

PMCF or Post-Marketing Clinical Follow-Up is a cornerstone of the Medical Device Regulation 2017/745.

This is why I took the opportunity to ask some questions about it to Helene Quie from Qmed Consulting. I met Helene at Medica 2019 in Dusseldorf and she accepted to help the audience to have a better understanding of PMCF.

Helene was part of the podcast episode 40 where we discussed Clinical Evaluation Reports or CER and specifically about the way to prove the equivalence between devices.

PMCF is part of this big box that is PMS or Post-Market Surveillance and this can be a good strategy to start one so you can collect data from the market and use them to prove that your products continue to be safe. This is more important for products that are transitioning between MDD and MDR and which do not have data available.

Who is Helene Quie

CEO at Qmed-consulting – experts in creating value-based documentation for innovative medical devices getting access to the markets through strong and honest partnerships with our clients.

It is my vision to enable better health through close collaborations with large established or newly started medical device manufacturers, small venture based innovative companies, venture funds, notified bodies, hospital, doctors and nurses within a wide range of medical device products and concepts from high-risk complex products such as heart valves with biological tissue to lower risk class products such as dental care products.

I believe that we through our trusted partners and colleagues can change the treatment of sick patients – making sure frontier products reach the patients and end-users, saving patient’s lives.

Together with the Qmed team, I have provided advice and/or operational services for several clients since 2006 within clinical and regulatory affairs, quality management, reimbursement, and health economics and market access with presence through our Qmed team and trusted partners in Europe, US, Canada, India, and Australia.

Links to this episode

Helene Quie Linkedin: https://www.linkedin.com/in/helene-quie-863a323/
Qmed Consulting: http://www.qmed-consulting.com/
MEDICA Video: https://youtu.be/bBC2TwL6HFo
Episode 40 – CER product equivalence: https://podcast.easymedicaldevice.com/40
Easy Medical Device Youtube Channel: youtube.com/c/EasyMedicalDevice?sub_confirmation=1

The post Post-Marketing Clinical Follow-up with Helene Quie (PMCF) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

I wish you a Happy New Year 2020 with Monir El Azzouzi

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 30 Dec 2019 00:00:00 +0000

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This is the last episode of 2019. Episode 56 is a celebration of all that was accomplished during this year. I wanted to review some topics that were discussed and thank some of the people that were part of it.

The Year 2019 will be my Podcasting Year as it’s been 1 year that I started this podcast and I am really proud of its success. I will also celebrate the people that were part of it. I received some great guests and this was really a success for me. I was able to convince some people that I was admiring to come and get interviewed by me. Imagine that you are following a person and that now you are able to ask this person important questions. I feel really lucky.

I will also talk about some personal things that happened to me as I moved from employee to entrepreneur. I am now my own boss and this is so great. I can do what I want without asking the authorization.

I will also mention the future of Easy Medical Device. And I hope you will be part of it. I really appreciate to serve you and want to continue if you authorize me.

2020 will be a year with a lot of challenges and events. For 2 years I am talking about May 2020 and this is soon now. So we will see if this will be a catastrophe or if this will be a great moment. Any way I will be here to share that with you.

I wanted to finalize this by saying Thank You for all your great messages. Don’t stop please as this motivates me. I am really happy that I was able to support a lot of you.

I want to close this by saying that I WISH YOU A HAPPY NEW YEAR and I really wish you to be happy in your life personally and professionally. This is a great feeling.

The post I wish you a Happy New Year 2020 with Monir El Azzouzi appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

6 ways to collect Clinical Data with David Rutledge

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 23 Dec 2019 00:00:00 +0000

As you may know, the new Medical Device Regulation is asking for more Clinical Data to be able to prove that your product is safe. I am sure that you are wondering about the possibilities for you to collect clinical data for your product.

In this episode, David Rutledge from Global Strategic Solution will share with us 6 ways to collect clinical data for your Medical Devices. He will also help you understand which one is more suitable for your situation.

David also shared with us a presentation that you can download from the links listed below. Don’t hesitate to reach our to him if you have more questions.

Who is David Rutledge

David R Rutledge, Pharm.D., FCCP, FAHA is a results-oriented consultant for clinical evaluation and investigation, clinical risk management, regulatory, and quality. He brings 25 years’ global experience with agencies such as US FDA, Brazil ANVISA, Mexico COFEPRIS, NMPA (China FDA), S Korea Ministry of Food and Drug Safety, Hong Kong, Malaysia, Health Canada, Australia TGA, Thailand FDA, Japan PMDA, EMA, Saudi FDA, CDSCO of India and several Notified Bodies, e.g., BSI, DEKRA, Medcert, and TÜV SÜD.

He previously accepted a 4-year appointment from the United States Department of Health & Human Services to serve as the Industry Representative on the FDA’s General Hospital and Personal Use Devices Advisory Committee in FDA’s Center for Devices and Radiological Health (CDRH).

He is certified as a Lead Auditor for Quality Management Systems ISO13485 and holds certificates for Design Control, Risk Management, Six Sigma, and CAPA. Dr. David R Rutledge was formerly a Director with Abbott Medical Devices in Global Clinical Research and then Global Regulatory Operations. He has managed budgets up to $23.3 million.

Class I Medical Devices under MDR with Erik Vollebregt (PART 2)

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 16 Dec 2019 00:00:00 +0000

In this second part of the discussion with Erik Vollebregt, we will continue to help Medical Device manufacturers regarding the MDR Corrigendum 2. But we will also include more information about pure Class I devices.

The manufacturers with only class I devices will be surprised as there are also more requirements they have to follow per MDR. For example the creation of a QMS, the registration of economic operators, UDI…

So you should really understand those requirements as this can also increase the cost. I used the example of someone contacting me from the US to register an FDA class 1 product in EUROPE. And when I listen to him all the requirements and the cost of it, he was really surprised.

Learn to remain compliant just by listening to this episode.

Who is Erik Vollebregt

He actively contributes to law and policy development at the national and EU levels via membership of specialized committees at branch associations and the European Commission. Erik also works as an arbitrator in medical devices related disputes and is regularly retained as an expert witness in foreign litigation. Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish.

Link to the episode

Episode 53: https://podcast.easymedicaldevice.com/53
Erik Vollebregt Linkedin: https://www.linkedin.com/in/erikvollebregt/
Axon Lawyer Website: https://www.axonlawyers.com/
Slide Presentation: https://www.slideshare.net/ErikVollebregt/mdr-and-class-i-medical-devices-presentation-203092176
CEN/TR 17223:2018 MDR vs ISO 13485: http://tidd.ly/830baa
Blog post on Corrigendum 2 (Erik Vollebregt): https://medicaldeviceslegal.com/2019/12/09/corrigendum-2-and-the-potential-consequences-for-class-i-devices/
Corrigendum 2 link: https://data.consilium.europa.eu/doc/document/ST-13081-2019-INIT/en/pdf
Class I technical file template: https://school.easymedicaldevice.com/shop

The post Class I Medical Devices under MDR with Erik Vollebregt (PART 2) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Corrigendum 2 – Changes for Class I Devices with Erik Vollebregt (Part 1)

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 09 Dec 2019 00:00:00 +0000

There are some changes to some Class I devices. But at the time of this episode, there is still 1 vote remaining before acceptance of the Corrigendum.

Following the release of Corrigendum 2 of the Medical Device Regulation MDR 2017/745 and IVDR 2017/746, there is a significative change related to Medical Device class I that is up classified.

In this first part of this podcast episode, I have invited Erik Vollebregt to clarify the situation and help us understand the consequences of this corrigendum.

If you are a class I manufacturer, you need to look at that as there will be a lot of information that can help you. There are also a lot of consequences if you are not compliant, even RETROSPECTIVELY.

In part 2 of this podcast that will be published the following week, we will focus on pure Class I devices. Medical Device manufacturers should follow EU MDR 2017/745 from May 26th, 2020 and we are trying to help you understand the situation.

Who is Erik Vollebregt?

He actively contributes to law and policy development at the national and EU levels via membership of specialized committees at branch associations and the European Commission. Erik also works as an arbitrator in medical devices related disputes and is regularly retained as an expert witness in foreign litigation. Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish.

How to evaluate your Medical Devices in 3 Steps with Heikki Pitkänen?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 02 Dec 2019 00:00:00 +0000

This week we’ll start back with the basic steps to follow to evaluate your Medical Devices. It will seem basic for some people but you should not be so sure.

The new EU MDR 2017/745 is coming with many surprises and one of them is the fact that some products without a Medical purpose will now be considered as a Medical Device. So what you think is now changing.

With Heikki Pitkänen, we will explore 3 steps with you to evaluate your Medical Devices. It’S clearly mandatory for you to go through them.

Step 1: Qualification of your Medical Device
Step 2: Classification of your Medical Device
Step 3: Best route to assess your Medical Device

After you followed those 3 steps, you are nearly sure to have a project built on a clear foundation.

In this episode, Heikki offers you access to his platform so you can evaluate your Medical Device and learn more about it. Don’t forget to download the giveaway which includes the promo code.

Who is Heikki Pitkänen?

Heikki is the CEO and founder of Lean Entries Ltd., a group of regulatory experts in the area of global medical device regulations providing unique digital regulatory services as well as traditional consulting for the MedTech sector from academies and startups to multinational enterprises.

Heikki has two decades of experience from medical device development, certification, accredited testing and standardization, most lately as the Notified Body site manager at SGS. He is a member of the CEN-CENELEC Advisory Board for Healthcare Standards.

Responsibility of a Distributor in MDR & IVDR with Nicolaj Nitzsch

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 25 Nov 2019 00:00:00 +0000

The new Medical Device Regulation EU MDR 2017/745 and IVDR 2017/746 is providing some new vocabulary like “Economic Operators” and we will focus on one of them on this episode which is the Distributor.

The distributor has a particular responsibility within the new regulation. And this also means that some Distributors should update their Quality System or update some agreements they have with manufacturers.

Nicolaj Nitzsch is a Sales Manager at Scan-Med Norway and he is providing some support to understand what distributors should do to upgrade their system.

In this discussion, you will see that a lot of things were already in place for distributors before the new Medical Device Regulation, but with the MDR and IVDR, this should now be properly documented.

On the links below, I also included an article about another economic operator which is the European Authorized Representative.

Who is Nicolaj Nitzsch

With over 7 years of experience in the medical device filed where I over the years have developed a strong understanding of the importance of devices and the industry.

I have an education as a Data Technician Specializing in Infrastructure and have a strong mindset for business optimizing in the Nordic market.
I’m passionate about technology in general, Business Development and the industry of Medical and Health Tech because this is something that really can change the quality of life for patients.

Medical Device School: Product Development or Documentation creation?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 21 Nov 2019 00:00:00 +0000

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I am sure you were once on this situation where you started to develop a Medical Device and when you finished all the tests, and estimate that your product is good, then you want to put it on the market. When regulators ask you for your design documentation your mind then has a bug.

On this bonus episode of the Medical Device made Easy Podcast, Stefan Bolleininger, and Monir El Azzouzi will explain to you when you should develop first your product and when you should develop your documentation.

This episode can save you some time and understanding of the process. So don’t miss it

Who is Stefan Bolleininger?

Stefan Bolleininger is a key opinion leader and speaker for the medical device regulation MDR in Europe.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.

He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

Links from the Video

Easy Medical Device: https://easymedicaldevice.com
Stefan Bolleininger LinkedIn: https://www.linkedin.com/in/stefan-bolleininger-3a717028/
Medical Device Startups – Here are the secrets of success: https://www.medicaldesignandoutsourcing.com/medical-device-startups-secrets-success/
5 FDA Myths that Startup believe: https://podcast.easymedicaldevice.com/45/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post Medical Device School: Product Development or Documentation creation? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

EUDAMED is delayed, so What? with Richard Houlihan

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 18 Nov 2019 00:00:00 +0000

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In this 50th episode of the Podcast, we will talk about the announcement that was made this November 2019 by the European Commission of the EUDAMED Delay.

Richard Houlihan, CEO of EUDAMED.EU is my guest and will help us understand the situation and what should be done.

If you remember, Richard was on episode 25 of the podcast.
■ https://podcast.easymedicaldevice.com/25
All that Richard shared on this episode is still relevant. So don’t hesitate to listen back to it.

One conclusion of this episode is the fact that EUDAMED is delayed but MDR 2017/745 is not so you should continue your transition.

Who is Richard Houlihan?

Richard Houlihan has been in IT-related businesses for 25+ years. He holds a BSc in Computing and an MBA Information management. The varying IT roles have led to him living in several countries, working across 6 blue chips, 3 start-ups and 3 different directorates within the European Commission.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. After working for many years with big Healthcare company and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

Links from the Video

Richard Houlihan LinkedIn: https://www.linkedin.com/in/richard-houlihan/
Eudamed.eu Website: https://Eudamed.Eu
EU commission news about the delay: https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/eudamed_en
Eudamed Cheat Sheet + Promo Code: https://mailchi.mp/easymedicaldevice/eudamed_delay
UDI article: https://easymedicaldevice.com/udi/
Episode 4 – UDI: https://podcast.easymedicaldevice.com/4/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

The post EUDAMED is delayed, so What? with Richard Houlihan appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Literature Search for your CER with Ed Drower

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 11 Nov 2019 01:00:00 +0000

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As I have performed some Literature Searches and created some CER myself, I know the difficulty and time of doing that. But I also had to audit some CER reports and I am always surprised by the way this is done. With the new Medical Device Regulation EU MDR 2017/745, you will maybe have to update your CERs so this is why I decided to focus on this topic for this episode.

To help you perform your CER if they are based on Literature Search, I asked Ed Drower, Director of Regulatory Affairs at CiteMedical Solution, to come to explain to us the best practices to look for your Literature and how can you check that they are the most relevant for your Clinical Evaluation Report.

In this episode, we will also discuss timing to perform CER and Ed will share with us what Cite Medical Solution can propose to its customers. On the links below, Ed accepted to share some examples on how to create a CER.

In case you need more information on Clinical Evaluation Reports or CER, I propose you to listen again to the Podcast episode made with Helene Quie from Qmed Consulting. This is also one of the most listened episodes.

Who is Ed Drower?

Ed Drower is the Director of Regulatory Affairs at CiteMedical Solutions. In his last 10 years, he has supported filings and reviews of individual medical devices and combination products both in the US and Europe.

With decades of clinical research and drug development experience, Mr. Drower provides a broad perspective to regulatory compliance, document review, and preparation, as well as offering, managed solutions for the upcoming MDR release.

His company CiteMedical Solution is also helping its customers to perform the Literature Search described in this episode so don’t hesitate to contact them.

Medical Device School: How to build a Gap Assessment Tool?

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 07 Nov 2019 00:00:58 +0000

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On this Bonus Episode of Medical Device School, we talk about Gap Assessment with Stefan Bolleininger.

What do you understand when we say that you should perform a Gap Assessment? Which tools should you use for a Gap Assessment? We will give you our opinion but we really want also to hear from you.

In this episode, Stefan says also that we should not use Excel for a Gap Assessment tool. And that you should not mix Gap Assessment and Project activities.

We will also discuss the General Gap Assessment tools and the fact that your company is unique. So you should always adapt the tools you get to match your company structure. So much said in a few minutes.

On the links below, we propose some general Gap Assessment tools with the collaboration of the Regulatory Globe. Don’t hesitate to check the affiliate link in case you are really looking for something already built for you.

Link to the episode

Stefan Bolleininger LinkedIn: https://www.linkedin.com/in/stefan-bolleininger-3a717028/
Be-On-Quality Website: https://www.be-on-quality.com/
Gap Assessment Tools: https://www.regulatoryglobe.com?ref=1133
Medical Device School – CAPA issues: https://podcast.easymedicaldevice.com/mds1/

The post Medical Device School: How to build a Gap Assessment Tool? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

How to validate an eQMS with Jacob Sjorslev

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 04 Nov 2019 00:00:35 +0000

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After eQMS implementation, we talk this week about eQMS validation and Jacob Sjorslev from SimplerQMS is really providing some great value by answering all the questions that a Medical Device Company should ask when having such software.

The validation of an electronic Quality Management System (eQMS) is not the same as for a product. There is a specific standard dedicated to this case and Jacob will help you understand it.

When you listen to Jacob you can feel that he is really passionate about what he is doing and the way he explain the different processes make real sense. I liked it when he said that a Medical Device manufacturer should not start with an eQMS but with paper. This is not something that you hear from another software developer.

Who is Jacob Sjorslev

Jacob has been the VP of Business IT in a global medical devices company and started his career in business development and later became a project- and program manager.

Challenging local autonomy and willingness to change Jacob has been successful with a large portfolio of global digital transformation projects that have created common best of breed systems, best practice processes and a rock-solid method for implementing projects in the USA, Asia and the EU on time.

The results are optimized common processes, outsourcing of services, integrations with customers, external warehouses and suppliers and fast integration of acquired companies. The projects have contributed to growing the turnover with 250%, 650% on profit and 2500% on the share price.

The digital transformation experiences are now available for supporting Medical Device Startups with a cloud-based preconfigured and prevalidated eQMS system based on M-Files in Jacobs own company SimplerQMS.

Link to the episode

Jacob Sjorslev LinkedIn: https://www.linkedin.com/in/jacobshyrdum/
SimplerQms Website: https://www.simplerqms.com/
eQMS validation pdf to download: https://mailchi.mp/easymedicaldevice/eqms_validation_giveaway
Episode 11 – Software Validation: https://podcast.easymedicaldevice.com/11
Episode 29 – 5 steps to create a Quality Management System: https://podcast.easymedicaldevice.com/29/

The post How to validate an eQMS with Jacob Sjorslev appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

How to implement an eQMS with Jacob Sjorslev

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 28 Oct 2019 00:00:16 +0000

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If you are a Medical Device manufacturer, for sure you have a Quality Management System (QMS). But the next question is more about the technology you are using to keep this QMS alive. Is it the old paper or is it a digital solution?

In this episode of the Medical Device made Easy Podcast, Jacob Sjorslev, CEO of SimplerQMS will be explaining to us how to implement an eQMS or electronic QMS.

What is funny, is that even if he developed the SimplerQMS solution, he does advise to not start immediately with an eQMS when you are a young company. So, let him explain to you how he sees this kind of project and how you can make it a real success.

At the end of the episode, he also made an offer to the first people contacting him:

A checklist to help you implement correctly your eQMS
A free workshop to develop your eQMS implementation plan with your customized solution

I hope this will be really helpful to you.

Who is Jacob Sjorslev?

Jacob has been the VP of Business IT in a global medical devices company and started his career in business development and later became a project- and program manager.

Medical Device School – Most important issues on your CAPA (ISO 13485)

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Thu, 24 Oct 2019 00:00:29 +0000

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The CAPA system is an important pillar of your Quality Management System (ISO 13485 or FDA QSR) and we have identified a lot of issues that companies are doing with it.

For this episode, I have invited Stefan Bolleininger from Be-On-Quality so we can discuss this topic and share with you our experience.

CAPA means Corrective Action Preventive Action and is used when an issue is identified. But there are many parameters to do a good CAPA and there are also some good practices to avoid to show the wrong one to an auditor.

Let us know if you were in the same situation and what you have done to correct it.

The post Medical Device School – Most important issues on your CAPA (ISO 13485) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Medical Device Disruptions at Hospitals with Stefan Krojer

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Sun, 20 Oct 2019 11:01:13 +0000

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Can you imagine arriving at a Hospital and telling you that they cannot plan a surgery because there is disruption on the delivery of a product? I am sure you are thinking this is impossible. But we already talked of this possibility with the upcoming Medical Device Regulations (MDR 2017/745 & IVDR 2017/746) and the Manufacturer’s difficulties to comply with it.

Let’s ask then Stefan Krojer who was working at the Berlin Johanniter Hospital as responsible for procurement. He had to manage some difficult situations and provide his expertise and some solutions.

He decided to start a new initiative where he collaborates with a Startup to develop a platform that will connect Hospitals with medical device manufacturers or distributors to reduce the number of disruptions. Learn more about it in this episode.

Who is Stefan Krojer?

Stefan Krojer is an experienced hospital procurement and supply chain manager.

With his blog “Future Hospital-Procurement” he is looking for more transparency and dialogue between the partners in hospital procurement.

His specialty is digitization, innovation, and collaboration. His study “Future Hospital Purchasing 2025” has shown that the buyer of the future needs to standardize and digitize all his own data and processes. In order to activate the role as a game-changer, he must find new solutions with the help of external value creation partners and internally implement them successfully.

As a connoisseur of corporate goals, you not only buy products, but also new market and business opportunities.

5 FDA Myths for Start-Ups with Justin Bushko

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 14 Oct 2019 00:00:07 +0000

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Start-Ups are really doing great to develop the Medical Devices that patient needs but they should satisfy Investors and also Regulators. This can create some situations.

This is why Justin Bushko will share with us his experience with Start-Ups by listing 5 FDA Myths. I am sure you’ll recognize some of them as maybe your company experienced that.

At the end of the show notes, I will also provide you a link to download a document that summaries our discussion with Justin. This can be helpful if you want to teach your team about some of them.

Who is Justin Bushko

Justin Bushko, Principal of Concise ENGINEERING, holds a BS in Electrical Engineering from Grove City College and an MBA in Leadership & Management from the University of South Florida. CONCISE offers support in Program & Project Management, Electrical Product Safety and Usability in the Medical Device Industry.

Concise also offers support to Start-Ups focused on the development of embedded systems. Justin has provided New Product Development solutions to industry for the last 20 years. He has led design teams to launch or sustain over 100 products.

Additional certificates include Project Management Professional (PMP), ASQ Software Quality Engineer, Six Sigma Black Belt, Design for Six Sigma, Lean Design, Kaizen and Root Cause Analysis.

GDPR & MDR for Medical Applications with Jovan Stevovic

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Sun, 06 Oct 2019 22:38:36 +0000

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GDPR is a well-known regulation now that is impacting all sectors as this helps to keep your data protected. So this also means that the Medical Device product should comply with it. But how to do that?

Jovan Stevovic is the CEO of Chino.io. He will help us to understand “What is GDPR?” and the link between GDPR and MDR 2017/745.

If your products are not compliant to GDPR, you can be heavily fined by the European member states so better understand it and put in place a strategy to protect the data of your customers or users.

But what are the elements to consider to be compliant to GDPR? and who should be on your project to support it and be sure that you are translating correctly the GDPR requirements to your design? This topic is really difficult as any miss can make your product not compliant. And the cost to be GDPR compliant can also be increased if you have not considered that from the beginning of your development.

Who is Jovan Stevovic?

Jovan Stevovic, Ph.D., is the co-founder and CEO of Chino.io, a platform that makes health applications GDPR and HIPAA compliant “out of the box”. Jovan has over a decade of experience in the health IT industry. He completed his Ph.D. at the University of Trento in 2014.

His research explored technologies and protocols to allow health data to be shared in a legally-compliant and secure manner. This work directly led to setting up Chino.io.

Currently, Chino.io helps companies in most EU states and the US to innovate in digital health.

Register your Medical Device in the US with Michelle Lott (FDA)

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Sun, 29 Sep 2019 22:59:21 +0000

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The challenge for Medical Device companies is to understand the different pathways to register their products in a certain region. On this episode, we will focus on the US FDA regulation for Medical devices.

To help us, I invited Michelle Lott from LeanRAQA. She will let you know what are the different steps to consider when you are trying to register a Medical Device in the USA.

We will talk about the product classification, the different registration procedures (510k, deNovo, PMA) and also about the Quality Management System acceptable by the FDA.

After listening to this episode, you will have a minimum understanding to place your product to the US market. But anyway if you need support you can contact Michelle or me to answer your questions.

Who is Michelle Lott

Michelle Lott is founder and principal of leanRAQA, which has supported 100+ companies with regulatory strategy, regulatory submissions, quality systems compliance, FDA audits, due diligence, technical support services – (and grief counseling, because dealing with regulators can be emotionally draining!).

New rules for the In-Vitro Diagnostic Industry with Maurizio Suppo

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Sat, 21 Sep 2019 23:01:15 +0000

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I know that on the title the focus should be on the In-Vitro Diagnostic situation but I promise that you will not regret this episode if you are on the pure Medical Device industry.

Maurizio Suppo, from QARAD (Guess about the acronym? Maurizio will reveal it at the end) is really a great guest and I really enjoyed to discuss with him about the situation regarding the IVD industry but also a lot of other topics related to Medical Device in general.

Here is a highlight of the topics we will discuss:

The urgency for the In-Vitro Diagnostic Industry to wake up and start engaging with the new IVDR
The risk if some manufacturers are out of business
Notified Body Situation for the In-Vitro Diagnostic Regulation (IVDR)
The proposals that could be made to the European Commission in case some manufacturers are late
The talk that Maurizio will do at the TOPRA Symposium 2019

I know a lot of people are asking me if this is possible for the European Commission that they extend the due date. Maurizio provided his answer and I would agree that this is a great solution.

Who is Maurizio Suppo?

Maurizio Suppo obtained his Ph.D. in Molecular Biology from the University of Turin. He held executive positions at several world-renowned IVD companies and was the Director of the European Diagnostic Manufacturers Association (EDMA). Maurizio joined Qarad in 2012 and became co-owner in 2016.

Podcast Transcript

Welcome to the Medical Device Made Easy podcast. Here is Monir El Azzouzi from easymedicaldevice.com. And today we will talk again or once more, one more time about IVD, so, in-vitro diagnostic manufacturers. This is a topic that is less discussed currently because we are really focused on the MDR. But I wanted to find some that can help us to understand the situation for IVD manufacturers currently. And for that I have with me Maurizio Suppo from QARAD who will be our guest today, and he will really guide us through the situation for IVD manufacturers and will help us also to know what they should do already now to be in a good shape for the future. So, Maurizio, welcome to the Medical Device Made Easy podcast.
Thank you, Monir. I hope I will be able to give some useful information for the audience.

Introduction of Maurizio Suppo

Yeah, I’m sure you will be doing that. So just for the beginning, Maurizio, can you just introduce yourself for the audience?
Yes, Italian. I work in the IVD industry for more than 33 years always in the quality regulatory environment. So that gave me a good chance to follow up from a situation that in the beginning, Europe was fragmented. There were countries without regulation for IVDs, countries with some regulations only for certain selected types of IVDs and countries with more general, you know, I remember France, Germany, then later on Spain, regulations. And then I lived through the, writing and the implementation of the IVD directive. Okay, that’s more than 20 years ago, of course. And now there is the second big step forward of the European Union in terms of legislation with the IVD regulation.

New Rules for In-Vitro Diagnostic

So it’s good then you have kind of all the history that happened for this kind of regulation, which will be great, and I think it will be great then for the audience to really learn about that and understand it. So, just for starting, so maybe we can still continue with the history for IVD (In-Vitro Diagnostic) and IVDR (In-Vitro Diagnostic Regulation). So, what is exactly the kind of changes that were happening there? What is the starting point now and what is our current situation regarding the products that will be now considered within IVDR?
Well, essentially the biggest innovation is that the European authorities have really decided to close the gap that we have in Europe versus the major legislations. And, of course, everybody has in mind FDA right. Because the situation was really, the delta was too significant. Think about high sophisticated products, which are in an area that is particularly sensitive to people, which are the tumor markers, in the United States’ FDA. Not only there, also in other legislations, they are quite highly regulated, all the cancer markers. And in Europe, they were under the directed framework. They were self-certified.
[Monir and Maurizio] Okay.
Companion diagnostics, the same. In Europe, self-certified IVDs and in the other legislations, very highly regulated. So the European authority really decided to close the gap by shifting the European legislative framework in a direction that is much closer to FDA in terms of complexity, okay, and I would say even cost, but not really exactly duplicating the modalities for the registration. So Europe, in that, retains its own unique approach. But overall, I have to tell that clearly the cost of compliance is going up. Okay, the cost of compliance for IVD companies, it’s clearly now being driven up, and that, Monir, as we were discussing before, it’s likely to have an impact on how the shape of the IVD market will look tomorrow. That brings me to highlight the major difference between the regulation and the directive is this revolution in the way that the products are classified. At most importantly is the revolution, the complete flip around of the ratio of products subject to the notified body control and the products that were self-certified.
Yeah, I can remember that. Yeah, before, so the classification was not really the same as for medical devices, and, as you mentioned, they closed the gap maybe with the FDA, but I think they also closed the gap between the medical device products and the IVD product because in terms of classification, the way you are considering them, we see similarities also now on the chapter, MDR and IVDR.
Totally correct. Totally correct. And the point, the point is that we have under the IVD directive, we had basically only 15% of IVDs under the scope of notified bodies, okay. And, you know, these are all the products that were in Annex II of the IVD directive, blood typing, hepatitis, toxoplasmosis, et cetera. And 85% were in the self-certification regime, and these are not my data. These are data from the European Trade Association, MedTech Europe, of course. And now these percentages completely flip. With some people, they are even saying that maybe only 10%, not 15%, of IVDs will be left in the self-certification regime. So you name a reagent, just name it, and every likely it will fall under the, the control of notified body. And that, let me add, it’s complete mind paradigm shift for many IVD manufacturers, which let’s face it, until now, they have happily lived in what I call the blue ocean of self-certification with no clue at all of what does it mean to work with a notified body.
Yeah, they never had any audit. They never had any unannounced audit, surprised audit, or any nonconforming managed .
Not only, not only that, which is an extremely valuable point, but they never had their technical documentation reviewed and challenged by an outside organization.
So it will be really a challenge also for them. I mean, a challenge for notified bodies, because there will be really a big need now of notified bodies for this area but also a chance for all the manufacturers where they can be surprised where before they were able to sell the product without any issue, and now they will be challenged by a notified body saying that maybe their product is not correct or not compliant. So it can, what happens,
And that, Monir, brings us to the other salient and significant point of the regulation, is the concern that industry has on the notified bodies. Because, okay, it’s clear, the European regulators sent a strong signal saying we want basically all of the IVD market under the control of notified body with very few exceptions, which are the products that remain in class A. And then it’s understandable, but on the other side, we are concerned, when I’m saying we is consultants, of course, industry, of the fact that the notified bodies, the European authorities, they have raised the bar so high for notified bodies in terms of competence, in terms of independence, needles to mention the joint assessment audits that notified bodies are subject. Also medical device notified bodies. Which are much tougher, okay, than the one, the processes in the past because, Monir, you know that in the past, notified bodies were nominated and monitored only by the authorities, the health authorities of the country that they belong, okay.
Yep.
And now with these joint assessment committees. So, the bar has been raised so high, and this has intimidated many notified bodies from applying to become a notified body for the Rs, for the regulations. So we have seen a significant reduction in notified bodies for medical device regulation that have applied, okay. Now we are at number four, nominated.
Yeah.
But you remember the story. You know, from 80 to 58 when this joint assessment audits came into place, and now from 58, I don’t know how many notified body have applied for the medical device regulation, probably 20, you know. It’s very secret. The European Commission doesn’t disclose data. But if we look at specifically at IVDs, you know, seven or eight have applied. And now we discovered that some have dropped out from the race. We all know about LRQA. We all know about UL. You understand. So, NSF was also a notified body that applied, particularly with the mission of being the partner for the IVD industry. And then it was forced to pull out of the race.
Yeah, so, as you mentioned, there is a big need of notified bodies. We have four notified bodies for MDR as of today. So, BSI UK, TUV SUD, Dekra, and recently yesterday, IMQ, at the day we record. But I checked again the list and the NANDO database, and zero are still for IVDR.
Which is understandable because the commission clearly wants to progress what is more urgent now. The most urgency is on medical devices because their deadline, their date of application, the end of the transition period is like 10 months away.
[Monir] Yeah, true.
But for IVDs, so it’s understandable that IVDs will come later. But what is more concerning is that with a third, you know, if we are lucky, we may have seven, maybe even, say, eight. You know, some people, they say six. It is roughly a third of the notified bodies for IVDs that we have today under the directive with a workload that has been estimated, again, not by myself, but by MedTech Europe, to be at least eight times as much as they have today.
Eight times for manufacturers or for the notified bodies?
No, for the notified body.
Okay, so they take eight time more resources–
With 1/3 of the notified bodies.
Okay.
So you do the math, and what is the result? The result is potentially long, long waiting lists. You know, these massive, massive amount of workload that will hit the notified bodies very hard when the time will come. And this is another excellent point that we, Monir, we already discussed before when were prepping this cast. Is that one thing is are the official deadlines that you see in the regulations, okay, everybody knows that it’s May 27, 2022, okay, for IVDs. But in reality, the real deadline that IVD manufacturers will be confronted is the date that the notified body will give them for submission. Because the notified body, if we look what is happening already today for the medical device colleagues, the notified bodies, they are saying, hey, if you want me to approve your medical device by the May 27, 2020, you know, next year deadline, you have to submit the documentation, the whole set of technical documentation to me by October this year. You know, we are almost in September, okay. September is few days ahead of us, and medical device companies may face an October deadline, which is like a month away for the submission of that. This is shocking, okay. These deadlines, these soft notified-body imposed deadlines, are the harsh reality with which industry will have to confront.
Yeah because I think everybody now is thinking May 2020, but at the end, it’s really not the right date. And I can also understand notified bodies, that they need some time also to review all the documents and then to be giving the approval. But yeah, it’s really, I mean, it’s a lot of time that is provided for them with less time for manufacturers to be ready also for the notified, for the medical device regulation. I think it will be the same that will happen for the IVDR. So we consider May 2022, but it will maybe October 2021 that everybody should–
Exactly, exactly.
Okay, so I see also as we discussed about MedTech Europe, I see how they were already alerting about all those kind of issues. And we start also to see a lot of countries like USA or Australia that starts also to provide some warning to the European Commission. What can they do? I mean, what is the consequence of that? Because everybody now is saying maybe we can extend the due date, et cetera, so what’s your idea on that?
But first of all, you’re totally right in the concern that it’s on the industry side. Everybody knows that MedTech Europe, Serge Bernasconi wrote a letter to the European Commission saying, hey, you know, this is, we have a certain sense of urgency, and the time is running out. What are the mechanisms that you are putting in place, you, the commission? And the European Commission replied very formally saying, yeah, for the moment, everything is fine. We are running along the, it’s normal cruising. But people are concerned. So what will happen? Nobody has the crystal ball, okay. I am kind of skeptical when I’m hearing people saying, yeah, you know, at the last minute, the European Commission will just push further back in the future the deadlines, which is, in other words, they will extend the transition period. I don’t think it will happen because it will imply an official modification of the regulation, okay, which is something that I don’t think the European Commission will consider. What more realistically, but this is purely my position, will happen, it is something like it happened already with the MDSAP. Our people that are on the line may understand, they know that MDSAP is the Medical Device Single Audit Program. And the Canadian authorities, they were crystal clear, you know, January 1st, 2019 is the deadline you need to be certified by MDSAP if you want to continue to sell in Canada. So what happened, so we are talking about facts, Monir, it is not speculation, okay. As you and I know, these are facts. What happened is that the Canadian authorities, they realized that there was also in this case for MDSAP certification, there was a bottleneck. So many companies have applied. They may even have received the audit but not the certification itself purely due to workload from these, of course, they are not called notified bodies. In the field of MDSAP, they are called auditing organizations. And so the Canadian authorities, they basically said okay, if you can show with documents that you have applied, maybe you even had the audit, and you are just waiting for the certificate to be issued, it’s okay. You are okay, don’t worry. Later on, they even went further. They said, okay, if you have applied, and you have not received the audit yet, okay, it is not your fault. We understand that the auditing organization are very busy. And there was a third step, which is really demonstrated how flexible the Canadian authority were. They said, okay, if you have already the CAMDCAS, which was the former Canadian regulatory regime certification, it is still okay, but provided that you will apply, and you will get the MDSAP certification. Okay, so these are facts. So what I think may happen is something similar. So, the European authorities may say, okay, listen, if you can show that you have contracted, not contacted unofficially because everybody can unofficially get in touch, but contracted the notified body, and you have made the application, raised your hand and said, we are ready. We have all the technical documentation, and our quality management system is okay. And the notified body had no time to come due to workload, I think that it’s very likely that the European authorities will say, you know what, your current CE mark, because, of course, they are directive-related CE mark, it’s okay. And it grants you continued access to the European market until the notified body will come.
No, it’s clear, and I think the European Commission should try to find those kind, I mean, to maybe disclose or mention about those kind of scenarios because it’s really important for manufacturers to be ready and not give up also. What I’m afraid of also is that some, that we have notified bodies that are giving up and maybe now we’ll have some small manufacturers that will also give up because they say it’s too much. There is too much thing, and we don’t want to invest money, where at the end, we know that we will not make it, et cetera, et cetera because of the deadline, so–
And that, sorry, to interject, Monir, but that is one of the concerns. I think, again, it’s me speaking, my opinion, but I think that these European regulation will change the shape of the European market, particularly, particularly for IVDs. The impact on IVD manufacturers will be much greater than medical devices because as you mentioned before, medical device manufacturers already were used to work with notified body. It’s not that they are totally facing a different environment. That will happen for IVD manufacturers. And that from what I’m seeing, honestly, our consulting company is very specialized in IVDs. We basically work with 70% of the top IVD players. So what I see for the moment, in a bullet statement, is that the big players, you bet, they are on it. They are already working since months, if not a year. And they are preparing very well. The small manufacturers, even some of the medium ones, they still have their head buried in the sand. And when they will wake up, for many of them, it will be dramatically too late.
Yeah, and as you mentioned, there is, I think, a lot of diversity in terms of products. And there is some product that exists maybe only with some small manufacturers and not with big ones. So, losing them, we can maybe lose a big part of the products that people are using and–
[Maurizio] Exactly.
This is maybe risk for patients at the end. Also risk to have no competition so that only big medical device can dominate the market.
Yeah, let me reframe that a little bit. I don’t think really risk for patient. The risk for patient doesn’t come from the fact that certain companies, small companies, won’t be able to offer their products, okay. I think that the risk for patients may come if the European Commission will not put in place these plan B mechanism, okay, that we were discussing before. If they will only apply a very, very strict mentality saying, hey, if you don’t have your MDR, Medical Device Regulation Certificate, you will not be able to place product on the market. If they take such a strict and rigid attitude, and they will take it by telling the notified body to take such attitude, really, there is the risk that certain medical devices, first, of course, because the deadline is coming earlier, and later on certain IVDs will not be available to patients anymore. And that would be bad, and it is so bad that that’s why I’m absolutely convinced, Monir, that the European Commission won’t let this happen.
And I’m sure also, and I hope they are listening to this podcast and that they really get some advices or get some suggestions so that they can .
What will happen on the IVD is a more subtle thing. Is that, indeed, the laboratories, if I would be a laboratory director, today, I have a very wide portfolio. And don’t get me wrong, they are good products, even the ones that are offered by small companies. Not necessarily they are bad quality. So for a laboratory director, you have very wide offer. And everybody knows as the fundamental rule of the market is that more, the more diversified the offer is, the more prices can be contained. If we will drive towards a future situation where small companies may not afford the cost of compliance, okay, what we were saying before, and slowly and gradually, the European IVD market will concentrate in the hands of the big players, which will have less competition and more capability to drive the market in the direction that they want.

What can QARAD do for you?

No, I completely agree with you. On that case, so what QARAD, so, what your consulting company can do? As you’ve said, you are really specialized in IVD (In-Vitro Diagnostic), so what are you doing actually for your customers?
Yeah, and again, with some exceptions, we are helping the big players to put in place their regulatory strategy for compliance, helping them to be very, very proactive to work with their potential notified bodies. Because, you understand, it’s an act of faith, right? You are working with your current notified body in the hope that it will become a notified body also for the regulation, okay. But I have to say that the big names, you know, maybe there will be some surprises, but most of the big names, I’m sure that they will become. But again, the big names, they stay on the fingers of two hands, even some less fingers, right? So, yes, the strategy of, first of all, identifying the products that are worth IVDR-izing. Okay, if you allow me to invent this new word.
That’s good one.
IVDR-ization, it is something that maybe not all products are worth having because you imagine there are products in the industry that are kind of at the end of their natural life cycle. They are, you know, old, The shape, the state of the art, okay, it’s moving a target, you know. Gradually, the state of the art is changing. Imagine the state of the art of a car. You are young, but you know, I’m almost 60. When I was driving age, the state of the art of cars were definitely different than what is today, right? So there is a natural obsolescence. So, the first step really is deciding what are the products that are worth moving on. And the second step clearly is mapping the intended purpose. Because you cannot, Monir, you cannot, and I’m sure you can do the parallelism for medical devices. You cannot make a serious gap analysis on the data you have or you don’t have unless you have very clearly mapped what is this product for, okay, because the intended purpose lists all the applications that the products has, and you need to have data for every single one of these applications. So let me make a very simple example. So if you say that a hormone, you have a test for a hormone, endocrinology, there are some hormones that also have a cancer marker application in certain situations, of course. And this is backed by literature, by scientific literature. If you make that statement, first of all, it will flip your product up in classification because a endocrinology test, pure and simple, falls in class B while a cancer marker falls in class C, right. But not only that. If you make the claim as a cancer marker, you should have data showing that your test, not somebody else tests, your tests can work in such application. So just to answer to your question what are we doing, we are helping them to prepare their documents. We offer the writing of scientific validity reports, which is a fundamental element of clinical evidence. And mostly what we are doing in these moments is we do IVDR readiness assessments. We review the technical documentation that they compile and they send us, and this is something that can be done in remote. Or my specialty is, I do on-site assessments of the regulatory readiness of the quality management system. Because you know, Monir, that the regulation, also the regulation for medical devices stands on two legs. One is the quality management system. You need to have a lot of processes that are required by the regulation, vigilance the periodic reports, et cetera, et cetera, post-market surveillance, post-market performance followup, which for IVDs, it is what post-clinical followup is for medical device. So, we do gap assessments on the quality systems and on the technical documentation.

TOPRA Symposium 2019

So yeah, I think it’s a complete offer, I think, for companies. And I saw also that you are on the agenda for TOPRA Symposium in Dublin October 1st on this year? So, what will be your talk there?
Yeah, I’m a regular contributor at TOPRA. I was also there last year in the symposium in Sweden. My topic this year in Dublin, other than drinking a good Guinness, it will be to talk about the, the clinical evidence implications, which are fairly considerable for the IVD industry, from an industry point of view. And the fact that I’m talking from an industry point of view is because I work with, as I told you, so many top players that I really see their approach, most of all their doubts in terms of clinical evidence. So that will be a very specialized talk on what is the currently industry, is the approach towards clinical evidence.
So we will see each other then then because I will be also at the TOPRA event. I will be covering the event, trying to see a lot of speakers also and do some small interviews with them, so yeah. And if you want then to meet here with me or also with Maurizio, then just contact us, and we’ll be there on October 1st and 2nd in Dublin for the TOPRA Symposium.
If you offer a good Guinness, I’ll be there.

How to follow-up with Maurizio?

No problem. Let’s do that. Maurizio, for the audience, so where can they follow up with you? So do you have a specific website or?
Yeah, yeah, yeah. It’s clear we have the QARAD. If you are not sure how to spell QARAD, it’s very simple because let me explain the acronym. It’s so simple. It’s Quality Assurance Regulatory Affairs Diagnostics.
[Monir] Okay.
QARAD. You know, you go to qarad.com, and you have all the information that you. And by the way, subscribe to the newsletter because the newsletter, of course, it is extremely laser-focused on IVD matters. But at least, you know, with a few days of delay from the official documents, you have them.
No problem, I will put that, everything on, I will put everything on the show notes or the links. I will put all your details also that people can contact you, and if they have more questions, they can call, go directly to you.
Yeah, thanks a lot, Monir, and let me add congratulations for this initiative, contacting many subject matter experts. And I think it’s a great way to defuse the knowledge about these regulations, and this is very needed particularly now.
Thank you, Maurizio, thank you very much. Really appreciated it. Okay, have a good day.
Bye-bye, bye.

The post New rules for the In-Vitro Diagnostic Industry with Maurizio Suppo appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Learn Post Market Surveillance with Natasha Bankowski

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Sun, 15 Sep 2019 23:02:48 +0000

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Her nickname is the PMS Queen as she can tell you all you need to know about Post Marketing Surveillance. Natasha Bankowski, Head Regulatory affairs and Pharmacovigilance at Kora Healthcare will really deliver you a masterclass on this episode of the Medical Device made Easy Podcast.

Her advice on this topic are really important as Post Marketing Surveillance is changing a lot with the new Medical Device Regulation MDR 2017/745. There are now some PMS Report, PSUR, PMCF, and EUDAMED that also enters the game.

One important take from this episode is to see the PMS as process connected inside all you Quality Management System and not only as a separated tool. It collects data from so many processes that it is really important to be careful when you are building that for your organization.

Who is Natasha Bankowski?

Natasha has experience working in both the Pharmaceutical and Medical Device Industry for over 12 years. She has worked across multiple areas including Quality Management, Regulatory Affairs, Medical Affairs, Pharmacovigilance, and R&D.

She has managed the Global Regulatory Affairs, Pharmacovigilance, and Medical Affairs Departments and has being successful in building the global footpath with registrations in over 150 countries.

She is currently working as the Head of Regulatory Affairs and Pharmacovigilance at Kora Healthcare in both the pharma and medical device space. She also lectures part-time in both Regulatory Affairs and Vigilance.

Product Equivalence for Clinical Evaluation Report (CER) with Helene Quie

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Sat, 07 Sep 2019 23:10:02 +0000

If you are really confused about Product Equivalence for your Clinical Evaluation Report or CER, then you are at the right place. Just hit the play button as Helene Quie from Qmed Consulting will be providing you some great information.

On this episode of the Medical Device made Easy Podcast, we will go through some specific aspect of Product Equivalence as:

Clinical Equivalence
Biological Equivalence
Technical Equivalence

This master class regarding Clinical Evaluation Report (CER) will help you be compliant for the new Medical Device Regulation EU MDR 2017/745. The mindset of Notified Bodies changes so they will be stricter regarding clinical aspects to prove the safety of your product.

Who is Helene Quie?

Helene Quie has a degree in Science specialized within cell biology from the University of Odense. Helene has 20 years of experience within the pharma and medical device industries working for inter alia Cook Medical A/S, H. Lundbeck A/S, AMBU A/S and Millimed A/S.

Her primary expertise is within the clinical and regulatory areas such as device development, quality management, project management, clinical trial execution, market access, and general management.

In 2006 she founded Qmed Consulting as a private consultancy company providing services within medical device development and clinical trials.

Episode 39 – Networking at Medical Device events with Lynda Wight

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Sun, 01 Sep 2019 22:30:48 +0000

Networking at events can seem really difficult. Saying “Hi” to persons without knowing them is a bit awkward. What is the objective of this approach?

If you are going to events to find new customers, to discover new technologies or to learn about the industry change, it is critical that you invest some time to research and prepare for it so you can maximize your return on Investment.

This is what Lynda Wight, Executive Director at TOPRA will help you understand on this episode. As an example, we will use the TOPRA Symposium 2019 to describe the situation.

This year, the TOPRA Symposium will be held in Dublin, Ireland – September 30^th to October 2^nd. If you have a moment during the breaks I’d be delighted to meet new colleagues and familiar faces at Booth 27 (RApport Global Strategic Services) where I will be discussing the transitioning of the MDR/IVDR amongst other topics!

Who is Lynda Wight?

Lynda Wight is a Fellow and Executive Director of TOPRA (The Organisation for Professionals in Regulatory Affairs), the international professional association for those in healthcare regulation.

She oversees all TOPRA’s activities, which includes over 30 training courses and conferences annually, MSc and Ph.D. programs, professional registration activities, Awards, and a peer-reviewed journal.

She has a BSc(Hons) in Biological Sciences and an MSc in Information Science and started her career in regulatory affairs for Merck, Sharp, and Dohme.

She then helped establish a consultancy and training business which became the international CRO IBRD Rostrum Global of which she was Executive Vice President, Europe.

Episode 38 – Be the Best Candidate Ever with Mitch Robbins

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 26 Aug 2019 00:00:19 +0000

Be the best candidate ever. If you are working on the Medical Device space, you are maybe looking for a new opportunity or a promotion within your company. To help you made the move on the best conditions, I invited Mitch Robbins from The Anthony Michael Group who is specialized in the recruitment of Medical Device employees.

On this episode, we will help you to understand:

The candidate value proposition
Tips on how to be considered the best candidate
How to get promoted within your company

For that, we will discuss specifically Quality and Regulatory Affairs skills. Because there are some criteria that you should consider when writing your profile on Linkedin or on your Resume. And I mentioned that for me Keywords is also an important part to sort the different CVs.

We will also talk about Mitch’s podcast which is helping you to improve yourself on this space by providing you some advice.

By the way, Mitch is the founder of the company but the company is called The Anthony Michael Group. Why? You´ll hear this great story as I will ask him this question.

Who is Mitch Robbins?

Episode 37 – Usability & Human Factor with Sharon Ayd

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 19 Aug 2019 00:00:26 +0000

If you have some difficulty to understand the concept of Usability and Human Factor, this episode is perfect for you. We will not specifically talk about theory but really about practice with a case study.

Sharon Ayd, CEO of Ayd Biopharma Consulting Group will be our guide. She will present to us a project where she was involved and where usability and human factor was key for its success.

Usability Study and Human Factor are really used a lot in the US, but now this is more and more demanded by regulators in Europe.

Who is Sharon Ayd?

Accomplished life science executive, with 30 yrs global experience in pharma/biotech & combination product/device industries. Founding member/C-level of three startups. Skilled in leading multi-national R&D drug development initiatives for complex biotechnology, pharmaceutical and combination products in large organizations & manufacturing environments. Expert knowledge in US FDA regulations. Have been responsible for ~100 drug approvals.

Episode 36 – How to choose your PRRC with Erik Vollebregt

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 12 Aug 2019 00:00:10 +0000

You will hear the acronym PRRC more and more as with the new Medical Device Regulation MDR 2017/745 and IVDR 2017/746 it is mandatory to have one at your company.

But what does it mean? This means Person Responsible for Regulatory Compliance. It will be a key person on your organization and you cannot appoint anybody at this role.

To help you understand what are the requirements, Erik Vollebregt from Axon Lawyers and myself will review with you the last guidance issued by MDCG. There is some clarification but there is still some unknown.

So, if you want to be compliant with the MDR, you need to listen to that.

Who is Erik Vollebregt?

Erik specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software and protection of personal data. He is an expert in life sciences regulation at EU and Dutch level, with a focus on contracts, regulatory litigation against competent authorities and M&A. Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms.

He actively contributes to law and policy development at national and EU level via membership of specialized committees at branch associations and the European Commission. Erik also works as arbitrator in medical devices related disputes and is regularly retained as an expert witness in foreign litigation.

Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish.

Chambers Europe 2017 about Erik:

He is known for his specialism in regulatory work, which covers medical technology, devices, and products as well as for biotechnology. Clients confirm his strong capabilities, with one saying “he stands out to me. Whenever I work with lawyers he has been the best, with a solid scientific background. He has the perfect combination of skills and experience.”

Episode 35 – Digitalization of QA RA with Michael Kania

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 05 Aug 2019 00:00:56 +0000

If you haven’t jumped on the Digitalization train, I advise you to listen to this episode, because our mission will be to convince you to scrap your papers and start to use software.

This can save you time and avoid some bad situation with the management of your documents. I will tell you a story at the beginning of the episode and if you are in this situation, then you should think of Digitalization of your QA RA documents.

To help us on this journey, I have invited Michael Kania from Meddevo.com. He will explain to use the advantage of Digitalization and also present his solution that is dedicated to some regulations as MDR or IVDR.

Who is Michael Kania?

” The medical device regulation is without question a big challenge for every manufacturer. At the same time, there is a shortage of professionals. I would like to show you how digitalization can help your company reduce costs, increase compliance and master MDR. ” by Michael Kania

Links from the episode

Linkedin Michael Kania: https://www.linkedin.com/in/michaelmkania/
Meddevo: https://meddevo.com

The post Episode 35 – Digitalization of QA RA with Michael Kania appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Episode 34 – Real-World Data for Medical Devices with Alethea Wieland

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 29 Jul 2019 00:00:26 +0000

With the new technologies as the Apple Watch, Fitbit or other application, we can now collect more data or more Real World Data.

This will be the topic of today´s podcast. Alethea Wieland from Clinical Research Strategies will help us understand the concept of Real World Data for Medical Devices.

What can we do with this information?
What are the parameters we should consider?
Can we show them to Regulators to confirm our products are safe?

We will try to answer all those questions.

Who is Alethea Wieland?

Alethea Wieland is Founder and President of Clinical Research Strategies, LLC, an executive-level management consulting firm and contract research organization for the life science industry established in 2011.

Her focus is on offering agile, flexible staffing models for clinical trial resourcing; training and managing resilient, high-performing clinical operations teams using human-centered design techniques; and, mitigating risks of clinical trials by facilitating the best Sponsor-CRO partnerships who practice accountability, compliance, and transparency.

She is an advocate of strong contractual arrangements, and frequently meeting with regulators and numerous stakeholders which results in a win-win mindset. Learn more by connecting with her on LinkedIn, and by visiting her website at www.clinicalresearchstrategies.com.

Links

The post Episode 34 – Real-World Data for Medical Devices with Alethea Wieland appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Episode 33 – Notified Bodies Lay Down Service with Erik Vollebregt

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 22 Jul 2019 00:00:31 +0000

► Webpage: https://podcast.easymedicaldevice.com/33

As we are changing the Medical Device rules, we need to certify new Notified Bodies in Europe. With the new MDR 2017/745 and IVDR 2017/746, all Notified Body should apply for new accreditation.

But apparently, this new regulation is not so easy and many Notified Bodies decided to not apply first. Then we have Notified Bodies that applied but decided to Lay Down Service (LRQA, UL, Intertek, QS Zurich…).

So what are the consequences for Manufacturers that have a certificate with these Notified Bodies?
What should they do to continue the business?
Is there something the member states can do to help them?

Erik Vollebregt, from Axon Lawyers, will help to answer those questions. He will tell you exactly what you should do and also what are the consequences for your business. We will also add Brexit on the equation to see if this can be worst.

Who is Erik Vollebregt

Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish.

Chambers Europe 2017 about Erik:

He is known for his specialism in regulatory work, which covers medical technology, devices, and products as well as biotechnology. Clients confirm his strong capabilities, with one saying “he stands out to me. Whenever I work with lawyers he has been the best, with a solid scientific background. He has the perfect combination of skills and experience.”

Links from the Video

Erik Vollebregt blog: https://medicaldeviceslegal.com
Linkedin Profil: https://www.linkedin.com/in/erikvollebregt/
Twitter Meddevlegal: https://twitter.com/MedDevLegal
Axon Lawyers: https://www.axonlawyers.com/
Previous episodes with Erik: https://podcast.easymedicaldevice.com/14
UL Notified Body information: https://www.raps.org/news-and-articles/news-articles/2019/7/ul-uk-to-sunset-operations-under-eus-medical-devi
LRQA Notified Body Information: https://www.raps.org/news-and-articles/news-articles/2019/6/uk-nb-will-not-apply-for-eu-mdrivdr
QS Zurich Information: https://www.medtechdive.com/news/swiss-notified-body-to-exit-sector-heightening-eu-capacity-fears/557160/
Intertek information: https://pharmaintelligence.informa.com/resources/product-content/notified-body-capacity-team-nb-members-way-ahead-but-picture-clouded-by-brexit

Social Media to follow

■ Linkedin: https://linkedin.com/in/melazzouzi
■ Twitter: https://twitter.com/elazzouzim
■ Pinterest: https://www.pinterest.com/easymedicaldevice
■ Instagram: https://www.instagram.com/easymedicaldevice

The post Episode 33 – Notified Bodies Lay Down Service with Erik Vollebregt appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Episode 32 – Pakistan Registration Process with Muhammad Sohail

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Sun, 14 Jul 2019 22:59:38 +0000

In the Middle East, there are also some opportunities to market your Medical Devices and today we will talk specifically about Pakistan. Muhammad Sohail who is specialized in Pakistan Market will share with us more information and help us to register your products.

He will first describe the Pakistan market with some numbers and also the products that are currently imported. Then he will explain the different steps you’ll have to follow to register your medical device.

As there was an update on the regulation, it’s now easier to register your products. Muhammad Sohail accepted also to prepare a package of documents so you can already see what are the requirements. You can download them on the links section.

Who is Muhammad Sohail?

He is a successful and highly experienced professional, holding a degree of pharmacy. His experience of more than eight years combines extensive regulatory expertise of handling regulations of medical devices, drugs, biologicals, and alternative medicines.

He has also been appointed as Industry (Secondary) representative of Asian Harmonization Working Party (AHWP) by the Drug Regulatory Authority of Pakistan.

Episode 31 – First Regulatory Affairs Job with Karandeep Badwal

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Sat, 06 Jul 2019 23:05:15 +0000

You decided to move to Regulatory Affairs, but you don’t know where to start. Then this is the right episode for you. Because I met with Karandeep Singh Badwal and he experienced the same situation.

Karandeep will describe 3 ways to approach Regulatory Affairs. He described that also on a Cheat Sheet that you can download here.

One important thing to summaries the discussion is for you to open a LinkedIn account and really connect with people. Don’t hesitate to contact me also, I would be happy to connect with you.

Who is Karandeep Badwal?

Mr. Karandeep Singh Badwal is a Regulatory and Quality Contractor specializing in medical devices, his educational background is an MSc Pharmaceutical Quality by Design, however, has worked almost exclusively within the medical devices industry from multinational companies to startups since his graduation.

Links from the episode

Karandeep LinkedIn Profil: https://www.linkedin.com/in/k arandeepbadwal /
A cheat sheet of the episode: https://podcast.easymedicaldevice.com/wp-content/uploads/2019/07/Your-First-Job-In-Regulatory-Affairs.pdf
Medical Device Webinars: https://school.easymedicaldevice.com/courses-2/
Episode 21 – Master Regulatory Affairs: https://podcast.easymedicaldevice.com/21
Episode 10 – Understand MDSAP: https://podcast.easymedicaldevice.com/10
Episode 14 – Update MDR and IVDR: https://podcast.easymedicaldevice.com/14
TOPRA: https://www.topra.org/
RAPS: https://raps.org
Easy Medical Device Linkedin Group: https://www.linkedin.com/groups/8667959

The post Episode 31 – First Regulatory Affairs Job with Karandeep Badwal appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Episode 30 – Promotional Compliance with Darshan Kulkarni

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Sun, 30 Jun 2019 22:59:57 +0000

Episode 30 – FDA Promotional Compliance with Darshan Kulkarni

Podcast Episode 30 – FDA Promotional Compliance with Darshan Kulkarni

The topic of Promotional Compliance is really important in the USA. As you will hear on this episode, advertisement is everywhere and most importantly, the advertisement for Healthcare Products.

So to keep this topic safe, some rules are important to respect. And to explain that to us, I invited Darshan Kulkarni, Principal Attorney at the Kulkarni Law Firm. He will tell us what should be done to avoid to receive some non-pleasant letters from the FDA.

Who is Darshan Kulkarni?

Darshan is an attorney and pharmacist, and provides legal and regulatory advice to drug and device companies and their service providers including advertising agencies, and medical writing agencies. His services include reviewing and discussing privacy concerns, promotional review services for websites and sales pieces, and responding to titled and untitled letters.
He has previously served as VP of Regulatory Strategy and Policy for a global consultancy and has lectured in engineering, medical, and law schools all over the country. He currently teaches a course on the Promotion of Biomedical Products at the Univ. of the Sciences, serves on various editorial and advisory boards including serving as the current Chair for the American Bar Association’s Life Sciences Interest Group, and has written multiple book chapters on the promotion of medical products.

Links from the Podcast

Youtube Channel: https://www.youtube.com/channel/UC-HtL8mAonEPWZskP52xbQQ
Law firm website: https://www.kulkarnilawfirm.com
Darshan Podcast: https://www.darshankulkarni.com/
Twitter: https://twitter.com/fdalawyers
Darshan Linkedin profile: https://www.linkedin.com/in/darshankulkarni

The post Episode 30 – Promotional Compliance with Darshan Kulkarni appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Episode 29 – 5 Steps to create a QMS with Jason Lim

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Sun, 23 Jun 2019 22:59:24 +0000

Episode 29 – 5 Steps to create your QMS with Jason Lim

Podcast Audio Episode 29 – 5 Steps for a QMS with Jason Lim

The creation of a Quality Management System or QMS is a journey. Some companies consider that only as a formality to check the box and are able to sell medical devices. Others are really considering that as a tool for a long term journey.

To help Medical Device companies on this Journey, I have invited a Medical Device Expert on Quality Management System creation, Jason Lim which is the CEO of Stendard.io.

He will reveal to us his 5 step strategy to create a QMS and get certified. These steps seems obvious but you will see that some are stopping at step 1 and then fail.

Who is Jason Lim?

Mr Jason Lim has been a strong advocate of standardisation, starting off his career as a regulator in Singapore’s HSA and later on as a quality manager of a MedTech accelerator. His venture as an entrepreneur started off as a Quality and Regulatory Consultant and have worked with many MedTech companies across different device focus and classification. He also participates in an international working group and contributes to the development of world-class standards. He strongly believes that utilising technologies can further help more companies in implementing international standards, streamline business processes across the organisation and accelerate global growth. Stendard was born and the vision is to put quality at the centre of businesses and make it easier.

Today, more than 200 companies in the MedTech and Food industries from Korea, Germany, Australia, India and Singapore are successfully using Stendard Solution as part of their ISO certification, saving time and money.

Test of STENDARD

I wanted to test Stendard and see if I can create a QMS within 30 Minutes. Check if I reached the goal.

My Challenge – Create a Quality Management System in 30 Minutes

The post Episode 29 – 5 Steps to create a QMS with Jason Lim appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Episode 28 – OBL & OEM with Stefan Bolleininger – Part 2

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Sun, 16 Jun 2019 23:01:13 +0000

Episode 28 – OBL & OEM Model (Part 2) with Stefan Bolleininger (Easy Medical Device)

Podcast Episode 28 – OEM & OBL Model (Part 2)

On this second part of the episode on OBL & OEM Model, Stefan Bolleininger from Be-On-Quality will focus now on the OEM side (Original Equipment Manufacturer).

We will try to answer the questions?

What should do an OEM so his customers (OBL, PLM, Virtual Manufacturers) are capable to continue business with the new MDR 2017/745?
How they should prepare for a Notified Body Audit?
What are the documents they should supply without delivering all there secrets?

If you want to know more about the OBL side, you’ll need to go back to episode one https://podcast.easymedicaldevice.com/27

We will tell you how the OBL can be prepared for an audit to get CE certified.

Who is Stefan Bolleininger

Stefan Bolleininger is a key opinion leader and speaker for the medical device regulation MDR in Europe. He founded the be-on-Quality GmbH consulting agency to passionately support manufacturers during CE approvals or FDA approvals. This support covers the full chain of quality and regulatory requirements: Implementation, maintenance, audits, assessments, and inspections. In the area of “Risk Management and Usability for Medical Devices and Medical Networks”, he holds a teaching assignment at the the Technical University of Nuremberg and the VDI Technical Committee “Quality Assurance for Software in Medical Devices”.

Links from the Video

■ Be on Quality website: https://be-on-quality.com
■ Stefan Bolleininger LinkedIn: https://www.linkedin.com/in/stefan-bolleininger-3a717028/
■ OBL/OEM Article: https://easymedicaldevice.com/own-brand-labelling/
■ Episode 27 – OBL & OEM Part 1: https://podcast.easymedicaldevice.com/27

Social Media to follow

The post Episode 28 – OBL & OEM with Stefan Bolleininger – Part 2 appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Episode 27 – OEM & OBL Model with Stefan Bolleininger [Part 1]

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 10 Jun 2019 01:30:35 +0000

Episode 27 – OEM & OBL Model with Stefan Bolleininger

Podcast Episode 27 – OEM and OBL Model with Stefan Bolleininger [PART 1]

OEM and OBL – It’s been a few months that this question was asked to me and the interpretation of the MDR 2017/745 or IVDR 2017/746 was not really easy.

This is why I tried to find someone to help us to define if OBL/PLM/Virtual Manufacturer & OEM Model is still existing with the new Medical Device Regulation.

OBL: Own Brand Labeler
PLM: Private Labeling Manufacturer
OEM: Original Equipment Manufacturer

Stefan Bolleininger from Be-on-quality.com accepted to participate in the Medical Device made Easy Podcast and answer my questions.

He will define with us what is the best strategy to continue business and we will first start with the OBL/PLM/Virtual Manufacturer and on the second part, we will focus on the OEM.

Don’t forget to subscribe and provide a review to the Podcast if you like what I am doing on it. This will really help me. Thanks for your support.

Who is Stefan Bolleininger?

Stefan Bolleininger is a key opinion leader and speaker for the medical device regulation MDR in Europe. He founded the be-on-Quality GmbH consulting agency to passionately support manufacturers during CE approvals or FDA approvals. This support covers the full chain of quality and regulatory requirements: Implementation, maintenance, audits, assessments, and inspections. In the area of “Risk Management and Usability for Medical Devices and Medical Networks”, he holds a teaching assignment at the the Technical University of Nuremberg and the VDI Technical Committee “Quality Assurance for Software in Medical Devices”.

Episode 26 – IVDR preparation with Andreas Stange

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 03 Jun 2019 03:30:39 +0000

Episode 26 – Prepare for IVDR with Andreas Stange

Episode 26 – IVDR preparation with Andreas Stange

We talked a lot about the EU MDR, but we should not forgot that there are also a similar change that is happening to the In-vitro Diagnostic Medical Devices with the EU IVDR 2017/746.

Manufacturers should be ready by May 26, 2022 but this will be really a huge work for them. Before only 20% of the products needed a notified body for placing their products on the market. Now with the IVDR it’S 80%.

So how should they prepare for that? Dr. Andreas Stange from TÜV SÜD will be my guest and answer questions about this new regulation. He will provide valuable information for the manufacturers to really focus on their journey to get certified.

Who is Dr. Andreas Stange?

Link

Andreas Stange LinkedIn Profile: https://www.linkedin.com/in/andreasstange/
TÜV SÜD notified body: https://www.tuvsud.com/
IVDR 2017/746: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0746

The post Episode 26 – IVDR preparation with Andreas Stange appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Episode 25 – EUDAMED secrets with Richard Houlihan

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 27 May 2019 03:00:19 +0000

Episode 25 – EUDAMED secrets with Richard Houlihan

Podcast Episode 25 – Eudamed Secrets with Richard Houlihan

I know that you heard about something called EUDAMED but do you really know what it is? Do you really know what to do with it? and do you know how to prepare for it?

On this new episode of the Medical Device made Easy Podcast, I invited Richard Houlihan from EUDAMED.EU to discuss with us about the secret of EUDAMED.

What is interesting with Richard is that he was part of the project for the creation of this platform and how he created his own company to support manufacturers to be ready when EUDAMED will be launched.

On this episode we will answer few questions as:

What is EUDAMED?
When should we plan to use it?
What is the situation at the European Commission?
What companies should do to be prepared for it?
What Eudamed.eu can do to help?

If you have not already planned a project for it, you should listen to this episode because this will help you to be ahead of competition.

Don’t forget to subscribe to this Podcast and if you like it please provide a review on your preferred platform.

Who is Richard Houlihan?

Richard Houlihan has been in IT-related businesses for 25+ years. He holds a BSc in Computing and an MBA Information management. The varying IT roles have led to him living in several countries, working across 6 blue chips, 3 start-ups and 3 different directorates within the European Commission.

Episode 24 – Myths about consultants with Thomas McMann

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 20 May 2019 04:00:25 +0000

Episode 24 – Myths about consultants with Thomas McMann

Audio Episode 24 – Myths about consultants with Thomas McMann

On this episode, Thomas McMann from EPM Scientific who is in charge of the consultants and contractors recruitment in Switzerland will help us understand the difference between Full Time Employees (FTE), contractors and consultants.

He will also reveal to us the different myths that exist and we’ll discuss the reason people think about them. And you, for your Medical Device Regulation projects, have you hired a permanent employee, a contractor or a consultant. Please let me know on the comments and also the reason for that.

What is EPM SCientific

EPM Scientific is a global specialist recruitment company working exclusively in the Life Sciences industry. As an industry expert, we understand that the ongoing changes within the Pharmaceutical industry make the ability to attract and maintain industry-leading talent a key priority.

Episode 23- TOP 10 criteria to select a CRO with Alethea Wieland

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 13 May 2019 05:00:18 +0000

Episode 23 – CRO selection with Alethea Wieland

Alethea Wieland, President of Clinical Research Strategies will tell us what are the most important criteria to select a good CRO for your clinical trial project. This is critical to be able to get the right result and avoid losing money. There are so many elements to look at that Alethea will really go in detail on each aspect and provide good examples. So before to start the selection of your Clinical Research Organization, you need to listen to that. And if you want to get a pdf summary of the TOP 10 criteria to select a CRO that Alethea co-authored with Concetta Dudley, then look the link at the bottom.

If you like this show, please don’t forget to subscribe so you are notified when a new episode is released and if you can also provide me with a review, this would make my day.

iTunes Podcast: https://itunes.apple.com/fr/podcast/medical-device-made-easy-podcast/id1447060380
Spotify: https://www.spotify.com/
Stitcher: https://www.stitcher.com/s?fid=343133&refid=stpr
TuneIn: http://tun.in/pjgym
Google Podcast: https://www.google.com/podcasts?feed=aHR0cDovL2ZlZWRzLmZlZWRidXJuZXIuY29tL01lZGljYWxEZXZpY2VNYWRlRWFzeVBvZGNhc3Q%3D

Who is Alethea Wieland

Episode 22 – Clinical Trial with Alethea Wieland

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 06 May 2019 05:00:56 +0000

Episode 22 – How to perform a Clincial Trial with Alethea Wieland

Podcast Episode 22 – How to perform a Clinical Trial with Alethea Wieland

Webpage: https://podcast.easymedicaldevice.com/22

What is a Clinical Trial or Clinical Investigation? And should a Medical Device Company start a Clinical Trial or perform a Clinical Evaluation?

I invited Alethea Wieland from Clinical Research Strategies to help us have a better understanding. She will help beginners in this area to learn about the fundamentals of clinical trials.

This episode is really a masterclass for people that are not clear about Medical Device requirements for Clinical Trials or Investigation. We will talk about Europe but also the USA, and some other countries in the World. On the show notes, I also included some of the references that Alethea is mentioning as Standards, regulations or books to read.

This is the first part of 2 episodes. The second episode will be about “How to select a CRO?” So don’t miss it.

If you like this show, please don’t forget to subscribe so you are notified when a new episode is released and if you can also provide me with a review, this would make my day.

iTunes Podcast: https://itunes.apple.com/fr/podcast/medical-device-made-easy-podcast/id1447060380
Spotify: https://www.spotify.com/
Stitcher: https://www.stitcher.com/s?fid=343133&refid=stpr
TuneIn: http://tun.in/pjgym
Google Podcast: https://www.google.com/podcasts?feed=aHR0cDovL2ZlZWRzLmZlZWRidXJuZXIuY29tL01lZGljYWxEZXZpY2VNYWRlRWFzeVBvZGNhc3Q%3D

Who is Alethea Wieland

Links

► Clinical Research Strategies: https://www.clinicalresearchstrategies.com
► Alethea Wieland Linkedin: https://www.linkedin.com/in/alethea
► Alethea Wieland Twitter: https://twitter.com/alethea_wieland
► ISO 14155: http://tidd.ly/35fb9ead
► Meddev 2.7/4: https://ec.europa.eu/docsroom/documents/10336/attachments/1/translations/en/renditions/native
► ICH Good Clinical Practice: https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf
► Book: Rigor Mortis – Richard Harris: https://amzn.to/2ZXlphG

Don’t forget to subscribe to the Youtube Channel to be notified when I release another video.

The post Episode 22 – Clinical Trial with Alethea Wieland appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Episode 21 – How to master Regulatory Affairs with Samantha Alsbury

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 29 Apr 2019 05:00:20 +0000

Episode 21 – How to Master Regulatory Affairs with Samantha Alsbury

For those that want to work on a Regulatory Affairs department, the path can be difficult. We are looking for people that are experimented but before to have an experience they should start somewhere. So how to do that?

Samantha Alsbury from TOPRA (The Organization for Professionals in Regulatory Affairs) will share with us her thoughts on this.

How long to be ready to work in Regulatory affairs?
What are the important skills to have to be a good professional?
Is the transition from one regulatory field to another difficult to do?

She will really provide us all her knowledge on this and also give us some information about TOPRA. This organization can help you to perform this transition and also to improve on your Regulatory Affairs career.

On Sept 30th to October 2nd, 2019 TOPRA is also organizing an event in Dublin where you can network with professionals. This can also be good for your career.

Samantha Alsbury Bio

Samantha Alsbury completed her Ph.D. in Molecular Genetics at UCL in 2004, continuing with scientific research she moved into neurobiology using genetics as a tool at King’s College London before taking up a post as Senior Lecturer in Biomedical Science at the University of Greenwich. After taking on the role of Programme leader for a distance learning MSc in Biomedical Science for professional Biomedical Scientists Samantha joined The Organisation for Professionals in Regulatory Affairs (TOPRA) as the Head of Professional Development in 2016. In this role, she oversees the training, accreditation, qualifications and continuing professional development policy.

Useful Links

Samantha Linkedin: https://www.linkedin.com/in/samantha-cooper-n%C3%A9e-alsbury-761578 34/
TOPRA website: http://www.topra.org/
Twitter:
https://twitter.com/SamanthaAlsbury
Facebook Page:
https://www.facebook.com/topra.org/
Linkedin Group: https://www.linkedin.com/groups/1182787

Youtube Video: Episode 21 – How to master Regulatory Affairs with Samantha Alsbury from TOPRA

The post Episode 21 – How to master Regulatory Affairs with Samantha Alsbury appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Episode 20 – What is a Blockchain with Khuram Malik

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 22 Apr 2019 05:30:39 +0000

Episode 20 – Blockchain Healthcare with Khuram Malik

Blockchain is really a trending word that we start to hear on all social media. It’s apparently a revolution and to help the EasyMed Nation I decided to find someone to help us understand it. What is Blockchain?

Khuram Malik from Stratagem.io will be my guest this week and will try to explain to us this difficult topic. Blockchain can also be applied to the Healthcare Industry but how? Will this be a revolution for Medical Device products?

Who is Khuram Malik?

Khuram is Chief Strategist and Founder of Stratagem.io. Between 2013 and 2015 he has worked with over 150 Founders and Business Leaders around the globe helping them raise investment, improve their sales and marketing, hire great talent and develop amazing customer experiences.

Khuram loves game-changing start-ups, pretty data visuals, and good writing.

He is also the author of Billion Dollar Muslim; a calling to people of his community to embrace and adopt entrepreneurship wholesale.

Episode 19 – Rule 11 for Software Devices with Cyrille Michaud

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 15 Apr 2019 03:30:43 +0000

Episode 19 – Rule 11 Software Devices with Cyrille Michaud MD101 Consulting

Audio Episode 19 – Rule 11 Software Devices with Cyrille Michaud

With the evolution of software in the Medical Device industry, the legislation is also changing. With the MDD 93/42/EC software was not really a big topic, but today with Artificial Intelligence, Virtual Reality, Image recognition, Blockchain… it is important to consider it.

So the MDR 2017/745 created the classification rule 11 to provide some changes. Cyrille Michaud from MD101 Consulting is a software developer who works on the Quality and Regulatory field with his customers. He will help us to have a better understanding of this rule and how manufacturers should work with it.

About Cyrille Michaud

Based in France, Cyrille Michaud is managing partner as MD101 Consulting. He is an information technology engineer with experience in both software and Quality Affairs/Regulatory Affairs. Prior to his current position, he was project director in a medical imaging start-up. His main achievements were the ISO 13485 certification and the CE Mark and FDA clearances. The value he brings: solving technical and regulatory issues, building business plans and regulatory strategies for manufacturers of software medical devices.

Episode 18 – QA RA Recruitment situation with Petra Ognjenovic

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 08 Apr 2019 02:00:53 +0000

Podcast Episode 18 – https://podcast.easymedicaldevice.com/18

Podcast Episode 18 – Medical Device situation with Petra Ognjenovic

Since we have all those transition happening in the European Medical Device regulations, I wanted to understand the situation on the recruitment market. I contacted Petra Ognjenovic from SciPro Global to help us have a better view.

She is leading the lifescience department of the DACH region which are the acronyms of Deutschland (Germany), Austria and Switzerland (Confederation Helvetique).

We will talk mainly about the European Union situation for the Quality and Regulatory affairs people. She really provided great information as I was also no aware of the situation.

About Petra Ognjenovic

Hello, I am Petra Ognjenovic, a Life Sciences recruitment specialist.

I was born in the Netherlands, my parents are both Croatian and I grew up in Munich, Germany.

I studied two Masters Degrees in Human Resources Education & Management and Philosophy, Psychology & Economics; Following my graduation, I was approached by SciPro, a leading recruitment business in the Life Sciences industry, and offered the opportunity to be responsible for the DACH Region within medical devices.

I think that we have a huge responsibility within our industry and I am very happy that I have joined an international recruitment company full of very talented and passionate people, who, through our global network, are able to find the best talent in the market for our customers.

We are fundamentally, a people business and we love to give back to our communities. This year, we have partnered with Designability, a medical devices charity organisation. Designability create innovative medical devices to help people living with disabilities to have a better quality of life. This year, SciPro will be raising money to fund our own ‘Wizzybug’ a mobility device designed for disabled children under 5. For further information please follow this Link: https://www.sciproglobal.com/csr

One thing is for sure, I love my job and I love my industry so I am happy to be here today to share some insights, from the perspective of a recruitment consultant, within the Medical Devices Industry, during the MDR transition period.

Episode 17 – Unannounced audit stories with Florent Guyon

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 01 Apr 2019 04:00:47 +0000

Episode 17 – How to prepare for an unannounced audit with Florent Guyon

Audio Podcast – Unannounced audit stories with Florent Guyon

Do you want to know how to prepare for an unannounced audit? Florent Guyon starts to be an expert on that. Within 5 months in 2017, he received 5 Unannounced audits when he was working at Statice Innovation. It was crazy. He decided to make a Video to make fun of the situation and this was really hilarious (It is in French but can be automatically translated in English).

During this episode we will talk about:

Unannounced audits
The Biomedical Engineering School ISIFC
The Event “La rentrée du DM”

All the links are at the bottom.

Florent has more than 25 years of experience in the Medical Device field. He recently joined Nexialist as business developer but he still remains associate professor at the Biomedical Engineering School ISIFC.

Links

■ Nexialist: http://www.nexialist.fr/en/home/
■ Florent Guyon Linkedin: https://www.linkedin.com/in/florent-guyon/
■ Florent Video on Unannounced audits:https://youtu.be/ABa-slB2qWE
■ ISIFC Biomedical Engineering School: http://isifc.univ-fcomte.fr/pages/en/index.html
■ Event “La rentrée du DM”: https://www.larentreedudm.com/
■ Once Upon a time in America: https://www.imdb.com/title/tt0087843/

Youtube Video of the Interview with Florent Guyon from Nexialist

The post Episode 17 – Unannounced audit stories with Florent Guyon appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Episode 16 – From Disease to a Medical Device with Sean Hamilton

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 25 Mar 2019 02:00:42 +0000

Episode 16 – From Disease to Medical Device with Sean Hamilton

Sean Hamilton from War on Epilepsy is sharing with us its story and why his condition helped him to become an entrepreneur and create a medical devices company.

Sean is epileptic and he developed a device specifically for people with the same condition. This story is really powerful. Instead of just trying to live his life only, he is now trying to impact other peoples lives.

Sean is in the UK, so the Brexit can impact his project and we’ll talk about the compliance part of his project. Apparently, he already anticipated a lot of the issues and works with experts to be up-to-date.

About Sean Hamilton

My life has been a Rollercoaster from, at just 18 providing IT Support in a serviced desk space which resulted in experiencing the ups and downs of business as well as success and failure.
To even before that, with a Lifelong dream that I still have to this day of being a Paramedic, sadly due to many health challenges that was not & Is not possible, but my passion for helping people, Health, Medicine & Technology has not wavered.

My journey so far Includes the Peter Jones’ National Enterprise Academy in Amersham then onto to pitch at “Prysm Group’s Business show Midas Touch back in November 2010, was their youngest ever pitcher at just 19 having received praise & many offers of support from an incredible panel made up of the one and only Chelsey Baker an incredible serial entrepreneur, mentor, Model, Presenter, host and columnist, Rachel Elnaugh the founder of Red Letter days, Roy Seaman of Franchise Development services Last but by absolutely no means least Jonathan Pfahl MD and founder of the UK’s No1 Mentoring and Private funding organisation: Rockstar Group whom i took up the offer to join forces with & thus Rockstar Youth was born, The Experience working alongside Jonathan Is one I would not trade for the world!

Entrepreneurship is a lifelong journey full of twists & turns and different paths it has challenges certainly & rewards undoubtedly, It’s what you do with both that determines the person you will be.

Age & qualifications should not determine how experienced you are or how Succesful you are going to be, experience & success come by doing!
you win some, you lose some, Life isn’t just about the successes it’s as much about the failures. practice really does make perfect & don’t ever be afraid to ask for help.

I am a strong believer in “callaboration as a pose to competition, afterall working together we can achieve more”
You can’t do it alone & there is No “I” in team!

Certainly don’t be afraid to take that leap because Life isn’t about what if…

Book recommended by Sean Hamilton

LINK

Episode 15 – MDR & IVDR discussion with Erik Vollebregt Part 2

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 18 Mar 2019 03:00:17 +0000

Podcast Episode 15 – MDR & IVDR discussion with Erik Vollebregt – Part 2

On this new episode, we continue to discuss with Erik Vollebregt on the MDR and IVDR. This is the second part.

If you missed part 1, you should go to:
► https://podcast.easymedicaldevice.com/14/ https://podcast.easymedicaldevice.com/14/

On this part Erik is answering my questions on:

New regulation for Small and Big companies
Notified bodies reduction
Brexit and consequences for Notified Bodies
and also rule 11 for classification of software

Biography

Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish.

Chambers Europe 2017 about Erik:

References

Erik’s Linkedin Profile: https://www.linkedin.com/in/erikvollebregt
Erik’s Twitter: https://twitter.com/MedDevLegal
Medical Devices Legal Blog: https://medicaldeviceslegal.com/
AXON Lawyer: https://www.axonlawyers.com
PART 1: https://podcast.easymedicaldevice.com/14/

Youtube Video – MDR & IVDR discussion with Erik Vollebregt – Part 2

The post Episode 15 – MDR & IVDR discussion with Erik Vollebregt Part 2 appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Episode 14 – MDR & IVDR stories with Erik Vollebregt (Part 1)

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 11 Mar 2019 02:00:40 +0000

Episode 14 – MDR & IVDR explanation with Erik Vollebregt

Episode 14 – EU MDR and IVDR explanation with Erik Vollebregt

On this 2 part episode, Erik Vollebregt will open our eyes about the EU MDR 2017/745 and EU IVDR 2017/746.

On his blog, MedicalDeviceslegal.com, he share openly his opinion about Medical Device Regulations. As he is a lawyer at AXON Lawyer firm, he has this ability to tell us stories like if this was a speach done in a justice court.

I asked him all the questions about EU MDR and IVDR and also about Brexit which we will see more on Part 2.

Biography

Erik specialises in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software and protection of personal data. He is an expert in life sciences regulation at EU and Dutch level, with a focus on contracts, regulatory litigation against competent authorities and M&A. Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms.

Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish.

Chambers Europe 2017 about Erik:

He is known for his specialism in regulatory work, which covers medical technology, devices and products as well as biotechnology. Clients confirm his strong capabilities, with one saying “he stands out to me. Whenever I work with lawyers he has been the best, with a solid scientific background. He has the perfect combination of skills and experience.”

Links

Erik’s Linkedin Profile: https://www.linkedin.com/in/erikvollebregt
Erik’s Twitter: https://twitter.com/MedDevLegal
Medical Devices Legal Blog: https://medicaldeviceslegal.com/
AXON Lawyer: https://www.axonlawyers.com

The post Episode 14 – MDR & IVDR stories with Erik Vollebregt (Part 1) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Episode 13 – Brexit Talk with Richard Young

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 04 Mar 2019 05:00:51 +0000

Episode 13 of the Medical Device made Easy Podcast – Brexit Talk

We are around 1 month before the BREXIT planned on March 29th, 2019 and I asked Richard Young, Technical Director at Sensus Group located in the UK to talk to us about this situation.

Richard will provide to the Medical Device Industry affected by the Brexit situation some pieces of advice. What would they do in case they have done nothing due to Brexit? Which Notified Body to select? Will there be any disruption of products?

He answered all my questions and you can feel it’s really difficult for him also as there are so many unknowns.

Biography

Richard had more than 25 years’ experience in senior Quality Assurance and Regulatory Affairs roles in a diverse range of Medical Device and In Vitro Diagnostic (IVD) companies.

Having traveled the world honing his expertise and gaining an extensive range of industry contacts, Richard now feels he can independently offer a truly innovative range of services – all designed with you in mind. His goal is to provide you with exactly what you need, quickly and effectively.

Episode 12 – How to create an ISO Standard with Marcelo Antunes

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 25 Feb 2019 05:00:22 +0000

Episode 12 – ISO Standards Creation with Marcelo Antunes

On the Medical Device made Easy Podcast I invited Marcelo Antunes from SQR Consulting to help us understand how the ISO standards we are using are created. Do you know how ISO 13485, ISO 14971 are created? Who is deciding which rules to apply? Are you also angry because some of the requirements doesn’t make sense?

Marcelo Antunes will tell us everything. You’ll know how to create standards and also how YOU can participate in the creation of a Standard which is really important for manufacturers.

We will also discuss about the Elsmar Cove Forum that exist since 1996 and which is a great source of support for the Medical Device industry.

Marcelo Antunes Biography

Marcelo Antunes is a Regulatory affairs strategy consultant at SQR Consulting, São Paulo, Brazil. He has more than 18 years of experience in the medical devices field.

The focus of his work is in the compliance of the medical device during it’s lifecycle, based on regulations and standards. He is an expert in Brazilian regulations and CE marking of medical devices. He also works regulations worldwide.

He’s chairman of the Brazilian mirror to ISO TC 210 (Quality management and general aspects of medical devices) and ISO TC 194 (Biological and clinical evaluation of medical devices). He’s an expert member, appointed by Brazil, of all working groups of ISO TC 210 (quality systems, risk management, software, usability, symbols, and nomenclature) and ISO TC 194, and also some IEC committees, at the international level. He’s a member of RAPS and manager of the RAPS Brazil Network and maintains the Medical Device Expert News blog. He’s also a teacher of medical device development and regulatory affairs at a number of Brazilian universities.

Episode 11 – Medical Device Software Validation

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Sun, 17 Feb 2019 09:40:20 +0000

Medical Device made Easy Podcast – Episode 11 – Medical Device Software Validation

Bill Stamm and Rafael Blanco from General Digital Software Services are helping us to have a better understanding of Software Validation. This topic is critical for Medical Device Manufacturers as the Healthcare world start to get digital.

More digital products that contain a software, more software on the manufacturing side, more software to verify software. I mean, software are everywhere.

The new EU MDR is strengthening the requirements for Software and we need then experts to help. Bill and Rafael are specialized on this and they are the right SMEs to tell us exactly which mistake to avoid.

I will also ask them about artificial intelligence as this is a kind of software that is more complicated.

They also asked me to share with you some documents like the V-shape which describe the software validation process. Don’t hesitate to download it on the resource section.

All the details to contact Bill and Rafael are below so don’t hesitate.

Background

About Bill Stamm
Mr. Stamm is the Vice President of Software Services at General Digital Corporation. He leads the Software Services team in sales and business management, growing global customer relations and partnerships, and oversees all software development, certification, IV&V testing and documentation. Mr. Stamm joined General Digital in 2015. With over 25 years of experience in the field, his varied background has brought him from service and engineering into sales and marketing. Mr. Stamm has also owned several businesses and has worked as an international sales and marketing manager at various other technology companies, such as EMC and Practical Automation. Mr. Stamm holds degrees in Computer Engineering, as well as Business Administration and Management.

About Rafael Blanco
Mr. Blanco has extensive experience with Software Verification and Validation of Avionics systems and components. He has performed verification (integration testing, module testing, reviews) on Bleed Air Systems, Mechanical Actuators, Fuel Pumps, Fuel Tanks & Systems, Automatic Flight Control Systems, Engine Controls, Starters, Pneumatic Systems Equipment, Cooling Systems, Fly-by-Wire Systems and Flight Management Systems. With over 25 years of experience in testing and project management, he has successfully brought his customers through FAA (Transport Canada, JAA) certifications for DO-178 projects both as a Verification Engineer and a Project Manager.

About General Digital Software Services
The General Digital Software Services business unit has over 45 years of extensive software development, certification and testing expertise—including Independent Validation & Verification (IV&V)—in the most stringent safety critical environments in the world: medical (FDA, IEC62304, PMAs and 510(k)), industrial controls (IEC 61508, IEC 61131), aerospace & avionics (DO178), and pharmaceutical and general packaging and robotic equipment. Our services can encompass the full software life cycle from development to verification, or simply help with overflow work.

Resource

General Digital Software Services: http://gdsoftwareservices.com

Bill Stamm Linkedin:
linkedin.com/in/bill-stamm-64118113

Rafael Blanco Linkedin:
linkedin.com/in/rafael-blanco-54963836

Document PDF to download: Link 1 and Link 2

Medtech prediction 2019: https://podcast.easymedicaldevice.com/5

FDA – General Principles of Software Validation: https://www.fda.gov/downloads/MedicalDevices/…/ucm085371.pdf

Youtube Video – Episode 11 – Medical Device Software Validation

The post Episode 11 – Medical Device Software Validation appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Episode 10 – Understand MDSAP with Angelina Hakim

melazzouzi@easymedicaldevice.com (Monir El Azzouzi) — Mon, 11 Feb 2019 06:00:18 +0000

Episode 10 – Understand MDSAP with Angelina Hakim

On today’s show, I invited Angelina Hakim the CEO of Qunique which is an Agency helping customers on Regulatory projects and also provide some service as an auditor.

She has 12 years of experience in Medical Devices with manufacturers and consulting organization. She is MDSAP and ISO 13485 certified.

She will explain us how to get MDSAP certified and how to avoid certain pitfalls.

MDSAP stands for Medical Device Single Audit Program and this is a new way to get certified for companies that are selling products to the USA, Australia, Japan, Canada, and Brazil.

This is a recent program that helps manufacturers to get audited only once instead of many times by each organization.

Below was an infographic I created for one of my article on my blog Easy Medical Device.

Infographic

https://easymedicaldevice.com/mdsap/

Qunique

QUNIQUE provides medical device companies with customized solutions for quality management systems (QMS), supporting the implementation of new processes and training personnel appropriately.

QUNIQUE focuses on compliance and efficiency. Its services cover the whole range, from creating a template or a standard operating procedure (SOP) to implementing a full QMS in compliance with ISO 13485:2016, Medical Device Single Audit Program (MDSAP), US Food and Drug Administration (FDA) 21 CFR part 820, or ISO 9001:2015.

QUNIQUE understands the regulatory requirements for medical device manufacturers, including the EU medical device regulation (MDR), MDSAP, and the ISO 13485:2016.

Video

Video Podcast Episode

Resources

Qunique website: https://www.qunique.ch

Angelina LinkedIn:
linkedin.com/in/angelina-hakim-34b70225

Book recommendation Homo Deus: https://amzn.to/2UcomYl /

Easy Medical Device Article: https://easymedicaldevice.com/mdsap

Episode 6 – What are the 6 types of Medical Device Audits

The post Episode 10 – Understand MDSAP with Angelina Hakim appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Medical Device made Easy Podcast

Master UDI-DI: The New Layer Many MedTech Companies Don’t Understand

Understanding the UDI Structure

Why Master UDI-DI Was Introduced

Key Benefits

Challenges for Manufacturers

Timeline and Urgency

Best Practices

Who is Al Hajj Sam Mostafa?

Who is Monir El Azzouzi?

Link

Social Media to follow

Life After CE Marking: Why AI Medical Devices Need Continuous Monitoring

CE Certification Is Not the Finish Line

AI in the Real World: Performance Drift

Updating AI Devices: What Is Allowed?

PCCP: Enabling Controlled Evolution

Building a Mature AI PMS System

Who is Osman El-Koubani

Who is Monir El Azzouzi?

Link

Social Media to follow

The Fake QMS Problem: Why Your ISO 13485 System Will Fail an Audit

What Is a “Fake QMS”?

Why This Happens

1. Copy-Paste Systems

2. Template-Based QMS

3. Consultant-Driven Systems

What Happens During an Audit

The Core Problem

How to Build a Real QMS

Final Takeaway

Who is Monir El Azzouzi?

Social Media to follow

AI Medical Devices: What Notified Bodies Really Look For

Are AI Devices More Difficult to Certify?

Data: The Foundation of AI Certification

Clinical Evaluation for AI

Risk Management in AI

Performance, Validation & Continuous Learning

Key Takeaway

Who is Monir El Azzouzi?

Social Media to follow

Medical Device News APRIL 2026 Regulatory Update

These 3 podcasts will change how you see MedTech

EUDAMED Deadline 2026 – 7 Steps Every MedTech Company Must Prepare

Why EUDAMED Matters

The Biggest Mistake

The 7-Step Readiness Checklist

Risks of Delayed Preparation

A Practical Timeline

Final Takeaway

Social Media to follow

Medical Device News March 2026 Regulatory Update

Social Media to follow

IMDRF & Regulatory Reliance Explained: The Future of Global Medical Device Approvals

What is IMDRF?

Understanding Regulatory Reliance

Real-World Success Stories

Australia – TGA

Argentina – ANMAT

Brazil – ANVISA

The Role of MDSAP

The European Perspective

Looking Ahead

Who is Monir El Azzouzi?

Social Media to follow

IEC 60601 – From 2nd to 4th Edition: What Manufacturers Must Know

The Evolution of IEC 60601

What the 4th Edition Brings

Impact on Existing Devices

Integration into Design & Documentation

The Future of IEC 60601

Who is Monir El Azzouzi?

Social Media to follow

Defect Management in SaMD — From Chaos to Control

Understanding Defects in SaMD

Building a Compliant Defect Management Process

Advanced & Real-World Scenarios

Audit Perspective & Common Pitfalls