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Medical Device made Easy Podcast

easymedicaldevice
Medical Devices
Medical Device Regulation
AI Act
EU Battery Regulation
Regulatory Affairs
Quality Culture
ISO 13485
AFNOR
Corrective Action
Quality Assurance
Quality Management Systems
IVDR
Notified Bodies
Regulatory Compliance
Conformity Assessment
Radiation Sterilization
ISO 11137
Contract Manufacturers
Preventive Action
Correction

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

PublishesWeeklyEpisodes389Founded7 years ago
Number of ListenersCategories
BusinessEntrepreneurship

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Artwork for Medical Device made Easy Podcast

Latest Episodes

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... more

YouTube

Medboard

Sponsor: Medboard: www.medboard.com/

Europe

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

Team NB

Team NB p... more

YouTube

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.

T... more

YouTube

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 technologica... more

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Recent Guests

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
Richie Christian
Consultant at Wega Informatik specializing in software compliance for MedTech companies
Wega Informatik
Episode: How to Remediate a Design History File (DHF)
Aaron Joseph
Biomedical Engineer and Systems Engineer, Design Quality Consultant
Sunstone Pilot
Episode: Verification & Validation Explained — A Practical Conversation with Aaron Joseph
Florian Tolkmitt
Co-founder and CEO of ProLiance, a consulting company focused on clinical evaluation.
ProLiance
Episode: From Engineer to Clinical Evaluation Expert - The Journey of Florian Tolkmitt
Rob Packard
Founder and president of Medical Device Academy
Medical Device Academy
Episode: How to become a LEAD AUDITOR made Easy
Marina Daineko
Biocompatibility Consultant at Intrinsic Medical Group (IMG)
Intrinsic Medical Group
Episode: What is changing with the new ISO 10993-1 version 2025

Host

Monir El Azzouzi
A medical device expert specialized in quality and regulatory affairs, who hosts discussions and interviews to provide valuable insights into the medical device industry.

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 Kingdom2 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.

Many find it a crucial resource for staying compliant with evolving regulations and grasping complex topics in a simplified manner.
Listeners appreciate the podcast for its informative content and expert insights into medical device regulations and quality management.
The engaging format and informative interviews are often highlighted as strong points, making the show enjoyable and educational for professionals in the medical device field.

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.

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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?

Content focuses on providing insights and updates on the medical device industry, particularly emphasizing regulatory affairs and quality management. Episodes often feature expert interviews discussing critical topics such as compliance with standards like IEC 60601, software as medical devices (SaMD), and various aspects of risk management in product development. Unique to the content is the blend of technical advice and practical insights, making it valuable for both newcomers and seasoned professionals in the medical field. The podcast is likely an essential resource for those looking to navigate the complex landscape of medical device regulations effectively.

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How many listeners does Medical Device made Easy Podcast get?

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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! with Dr. Naveen Agarwal
3. HBR On Leadership
4. The Rest Is Politics
5. The Rest Is Politics: US

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

Medical Device made Easy Podcast launched 7 years ago and published 389 episodes to date. You can find more information about this podcast including rankings, audience demographics and engagement in our podcast database.

How do I contact Medical Device made Easy Podcast?

Our systems regularly scour the web to find email addresses and social media links for this podcast. We scanned the web and collated all of the contact information that we could find in our podcast database. But in the unlikely event that you can't find what you're looking for, our concierge service lets you request our research team to source better contacts for you.

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What guests have appeared on Medical Device made Easy Podcast?

Recent guests on Medical Device made Easy Podcast include:

1. Stephanie Grassmann
2. Leo Eisner
3. Anindya Mukherjee
4. Simon Foeger
5. Richie Christian
6. Aaron Joseph
7. Florian Tolkmitt
8. Rob Packard

To view more recent guests and their details, simply upgrade your Rephonic account. You'll also get access to a typical guest profile to help you decide if the show is worth pitching.

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