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 | 364 | Founded | 7 years ago |
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Number of Listeners | Categories | BusinessEntrepreneurship |
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 h... more
From Surgeon to CEO: Prof. Marc Possover’s Inspiring Journey in Medical Innovation
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 na... more
bersecurity 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 podca... more
Medboard
EUROPE
Guidance on the implementation of the Master UDI-DI - MDCG 2024-14 - rev.1 : health.ec.europa.eu/document/download/c8c6cca5-460e-410e-a325-be08bfc7dea6_en?filename=mdcg_2024-14_en.pdf
Updated - Notified bodies survey on c... 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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Apple Podcasts | #246 |
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Focusing on the medical device industry, this podcast provides crucial insights into the regulatory landscape and quality assurance processes necessary for successfully placing compliant medical devices on the market. Through a combination of expert interviews and informative discussions, the podcast covers a range of topics such as regulatory updates, the impact of artificial intelligence in compliance, and best practices for software as a medical device. Notably, it brings together industry professionals who share their experiences and knowledge, making it an invaluable resource for anyone involved in medical technology, from aspiring consultants to established professionals looking to stay informed about evolving regulations.
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Medical Device made Easy Podcast launched 7 years ago and published 364 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. Marc Possover
2. RJ Kedziora
3. Anindya Mukherjeeva
4. Adnan Ashfaq
5. Adam Isaac
6. Mitch Robbins
7. Pardeep Kaur
8. Ivan Perez Chamorro
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