
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.
| Publishes | Weekly | Episodes | 383 | Founded | 7 years ago |
|---|---|---|---|---|---|
| Number of Listeners | Categories | BusinessEntrepreneurship | |||

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 vali... more
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... more
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 provid... more
Medboard: www.medboard.com/
Europe
EMD Mag Issue 3 - For QA RA people: easymedicaldevice.com/emd-mag/
EU to simplify MDR and IVDR - Proposal ongoing: health.ec.europa.eu/document/download/25e7ea7c-cab3-40cf-86d9-d11f5e7744d... more
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Working in the medical field for many years, this podcast is a must-have to keep up-to-date with the regulation. I recommend
Munir shares the current changes and introduction of new information for the medical devices. If you are into MD then you should follow him.
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
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.
Even for someone inside the medical devices regulatory world I founded this podcast very useful through a well structured themes .
Key themes from listener reviews, highlighting what works and what could be improved about the show.
How this podcast ranks in the Apple Podcasts, Spotify and YouTube charts.
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This series offers insights into the world of medical devices, focusing on regulatory compliance and quality assurance. The typical episodes include discussions on current regulations, industry challenges, and interviews with experts in the medical device field. Noteworthy topics include lead auditor training, evolving standards such as ISO 10993-1, and the integration of artificial intelligence in quality control processes. The unique approach of blending educational content with expert interviews makes it a valuable resource for industry professionals looking to navigate the complexities of compliance in medical device manufacturing.
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Medical Device made Easy Podcast launched 7 years ago and published 383 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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Recent guests on Medical Device made Easy Podcast include:
1. Richie Christian
2. Aaron Joseph
3. Florian Tolkmitt
4. Marina Daineko
5. Helene Quie
6. Hatem Rabeh
7. Rob Packard
8. Marc Possover
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