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Artwork for Medical Device made Easy Podcast

Medical Device made Easy Podcast

easymedicaldevice
Medical Devices
Regulatory Affairs
Medical Device Regulation
Artificial Intelligence
ISO 13485
Risk Management
FDA
Quality and Regulatory Affairs
Quality Management Systems
Regulatory Compliance
Notified Bodies
Clinical Evaluation
EU MDR
Quality Assurance
AI Act
Medboard
MDR
Quality Management System
IEC 60601
Cybersecurity

My name is Monir El Azzouzi and I am a Medical Device Expert specialized in Quality and Regulatory affairs. And on this podcast I will help you place compliant medical devices on the market. For that I will share with you my knowledge or the one of others through discussion or interviews. I will invite experts in the area to tell you what you can do or the challenges you may encounter.

This podcas... more

PublishesWeeklyEpisodes401Founded7 years ago
Number of ListenersCategories
BusinessEntrepreneurship

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Artwork for Medical Device made Easy Podcast

Latest Episodes

Artificial intelligence is transforming healthcare, but developing an AI medical device is only part of the challenge. Manufacturers must also navigate certification requirements and maintain safety and performance throughout the entire product lifec... more

Sponsor Medboard

Medboard: www.medboard.com/

EUROPE

Europe Starts Regulating the Regulators - Implementing Regulation (EU) 2026/977: eur-lex.europa.eu/eli/reg_impl/2026/977/oj

EUDAMED is mandatory - Panic is raising: heal... more

YouTube

The FDA’s new Quality Management System Regulation (QMSR) officially became effective on February 2nd, 2026, replacing the legacy Quality System Regulation (QSR) framework that had been in place for nearly 30 years.

Three months later, the reality i... more

YouTube

A medical device’s intended use is not just a regulatory formality — it is the foundation of the entire product strategy.

In this podcast episode, Monir El Azzouzi speaks with Karandeep Badwal about how intended use influences classification, clinic... more

YouTube

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Recent Guests

Mathangi Srinivasan
Quality Assurance Manager at Abbott Vascular, industry veteran in QA and manufacturing
Abbott Vascular
Episode: FEEDBACK AFTER 3 MONTHS OF THE NEW FDA QMSR IS IN PLACE
Karandeep Badwal
Founder of QRA Medical and the MedTech Podcast
QRA Medical; MedTech Podcast
Episode: How can a proper Intended Use save your device?
Sandy Wright
Head of Devices at Scarlet, medical doctor by background
Scarlet
Episode: The Hidden Costs of UDI Mistakes in Medical Devices
Osman El-Koubani
Clinical engineer at Scarlet, specializing in software as a medical device and post-market surveillance
Scarlet
Episode: Life After CE Marking: Why AI Medical Devices Need Continuous Monitoring
Camille Petri
Principal Scientist at Scarlet; lead authority on clinical evaluation and AI/machine learning in devices
Scarlet
Episode: AI Medical Devices: What Notified Bodies Really Look For
Stephanie Grassmann
Managing Director, MedTechXperts
MedTechXperts
Episode: IMDRF & Regulatory Reliance Explained: The Future of Global Medical Device Approvals
Leo Eisner
Expert on IEC 60601 standards, involved for over 30 years in testing and writing standards for medical devices.
Episode: IEC 60601 – From 2nd to 4th Edition: What Manufacturers Must Know
Anindya Mukherjee
Co-founder and CEO at SQ Technologies, with over 20 years of experience in Software as Medical Devices
SQ Technologies
Episode: Defect Management in SaMD — From Chaos to Control
Simon Foeger
CEO and founder of Sifo Medical, specializing in consulting and training for medical device processes.
Sifo Medical
Episode: Validation & Supplier Management in MedTech

Host

Monir El Azzouzi
Host of the medical device regulatory-focused show and expert in quality and regulatory affairs.

Reviews

4.8 out of 5 stars from 105 ratings
  • Interesting podcast

    Working in the medical field for many years, this podcast is a must-have to keep up-to-date with the regulation. I recommend

    Apple Podcasts
    5
    Chrisc&d
    United Kingdom3 years ago
  • Up to date information

    Munir shares the current changes and introduction of new information for the medical devices. If you are into MD then you should follow him.

    Apple Podcasts
    5
    Naveen089
    Switzerland5 years ago
  • Great European / CE Mark / Int'l medical device regulatory resource

    This podcast is a fantastic resource for medical device regulatory around the world. He really delves into the hot topics and provides easy to understand information on some very relevant topics. I especially enjoyed the one on European medical device classification, didn't realize how hard it was for notified bodies to be accredited, the elements of an intended purpose, and leaned of parallels between IEc 62304 off the shelf software and FDA's Multifunctional guidance. I appreciate very much th... more

    Apple Podcasts
    5
    PharmRD222
    United States5 years ago
  • Amazing podcast!

    Thanks for creating these podcasts Monir! This is one of the best and enjoyable podcasts to keep updated with the new challenges related to the medical device compliance, regulatory affairs and quality. The format and the interviews with the medical device professionals are excellent. I am always looking forward to the next one.

    Apple Podcasts
    5
    Elisenda Gendra
    United Kingdom6 years ago
  • Very useful knowledge

    Even for someone inside the medical devices regulatory world I founded this podcast very useful through a well structured themes .

    Apple Podcasts
    5
    Abdullah Alshuhri
    United States6 years ago

Listeners Say

Key themes from listener reviews, highlighting what works and what could be improved about the show.

High-quality interviews with industry experts and sponsors.
Excellent resource for EU/UK MDR and global markets.
Clear, practical regulatory guidance that's easy to apply.

Chart Rankings

How this podcast ranks in the Apple Podcasts, Spotify and YouTube charts.

Talking Points

Recent interactions between the hosts and their guests.

IMDRF & Regulatory Reliance Explained: The Future of Global Medical Device Approvals
Q: What is IMDRF and why does it matter for patients?
IMDRF is a voluntary group of medical device regulators (now including industry representation) aimed at accelerating and harmonizing regulatory frameworks so that innovative devices reach patients faster, with a focus on safety and efficiency.
IEC 60601 – From 2nd to 4th Edition: What Manufacturers Must Know
Q: What should manufacturers do in light of the new developments of the standard?
Manufacturers should remain aware of the evolving standards and begin strategizing for compliance, as development cycles for products often take several years.
IEC 60601 – From 2nd to 4th Edition: What Manufacturers Must Know
Q: How have you personally seen the evolution of the standard?
The evolution has been towards more detailed documentation, risk management, and essential performance aspects, especially moving from the earlier editions focused mainly on safety.
Defect Management in SaMD — From Chaos to Control
Q: How we can manage software of unknown provenance or third-party components mainly?
The legal manufacturer owns the risk of that defect, but they do not necessarily own the fix and should collaborate with the supplier for resolution.
Defect Management in SaMD — From Chaos to Control
Q: How to ensure that there is good collaboration between the tech people, the developers and the quality and regulatory affairs team?
Have the entire team involved from the very beginning with a collaborative approach, ensuring both developers and testers understand the requirements together.

Audience Metrics

Listeners, social reach, demographics and more for this podcast.

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Frequently Asked Questions About Medical Device made Easy Podcast

What is Medical Device made Easy Podcast about and what kind of topics does it cover?

This show targets professionals navigating medical device regulations, quality systems, and market access. Episodes feature regulatory updates, practical guidance on EU MDR/IVDR, QMS implementation, AI in medical devices, post-market monitoring, and case studies from industry experts. A notable pattern is deep technical discussions led by a seasoned regulator/consultant, with guests from sponsor organizations and consulting firms who illuminate real-world pathways to compliant product launches. Listeners can expect actionable takeaways, step-by-step guidance, and insights into interfacing with notified bodies and regulators, making it valuable for advanced practitioners and teams preparing filings or looking to accelerate global market acce... more

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Which podcasts are similar to Medical Device made Easy Podcast?

These podcasts share a similar audience with Medical Device made Easy Podcast:

1. Global Medical Device Podcast powered by Greenlight Guru
2. Let's Talk Risk! Podcast
3. The Mel Robbins Podcast
4. TED Talks Daily
5. Economist Podcasts

How many episodes of Medical Device made Easy Podcast are there?

Medical Device made Easy Podcast launched 7 years ago and published 401 episodes to date. You can find more information about this podcast including rankings, audience demographics and engagement in our podcast database.

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What guests have appeared on Medical Device made Easy Podcast?

Recent guests on Medical Device made Easy Podcast include:

1. Mathangi Srinivasan
2. Karandeep Badwal
3. Sandy Wright
4. Osman El-Koubani
5. Camille Petri
6. Stephanie Grassmann
7. Leo Eisner
8. Anindya Mukherjee

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