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Medical Device made Easy Podcast

easymedicaldevice
Medical Devices
AI Act
Medical Device Regulation
EU Battery Regulation
Regulatory Affairs
Quality Culture
ISO 13485
IVDR Class D
AFNOR
Corrective Action
Quality Assurance
Quality Management Systems
IVDR
Regulatory Compliance
ISO 11137
Radiation Sterilization
Contract Manufacturers
Preventive Action
Correction
Summative Evaluation

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.

PublishesWeeklyEpisodes383Founded7 years ago
Number of ListenersCategories
BusinessEntrepreneurship

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Artwork for Medical Device made Easy Podcast

Latest Episodes

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

YouTube

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

YouTube

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

YouTube

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

Key Facts

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Contact Information
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Number of Listeners
Find out how many people listen to this podcast per episode and each month.

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Recent Guests

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
Marina Daineko
Biocompatibility Consultant at Intrinsic Medical Group (IMG)
Intrinsic Medical Group
Episode: What is changing with the new ISO 10993-1 version 2025
Helene Quie
Founder of Qmed Consulting, with nearly 20 years of experience in the medical device field
Qmed Consulting
Episode: From Zero to One: The journey of a CRO with Helene Quie
Hatem Rabeh
a medical doctor and medical engineer with a Master's in Medical Engineering and expertise in clinical evaluation
Episode: Automatisation of your QA RA job with AI
Rob Packard
President of Medical Device Academy, a regulatory and quality system consulting firm
Medical Device Academy
Episode: US Government Shutdown – What FDA can still be doing?
Marc Possover
Professor and surgeon, founder of NeuroGene AG
NeuroGene AG
Episode: From Surgeon to CEO: Building NEUROGYN AG Professor Marc Possover’s Journey
RJ Kedziora
Co-founder of Estenda Solutions, a digital health-focused software development and AI consulting company.
Estenda Solutions
Episode: The good, bad and uglyof using AIfor QA RA Compliance

Host

Monir El Azzouzi
A medical device expert specialized in quality and regulatory affairs, who shares knowledge and insights from both personal experience and guest contributions within the medical device sector.

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.

Listeners have highlighted the engaging presentation style of the host and the relevance of topics covered, making the content enjoyable to follow.
The podcast is praised for its insightful interviews and practical information applicable to compliance and quality assurance.
Listeners find the content to be an excellent resource for up-to-date medical device regulation information.
Audience members appreciate the educational nature of the discussions, noting they are suitable for both novice and established professionals.

Chart Rankings

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

Talking Points

Recent interactions between the hosts and their guests.

How to Remediate a Design History File (DHF)
Q: How should companies prepare for a remediation project?
Companies should treat the remediation as a project, assigning a capable project manager and involving cross-functional teams.
How to Remediate a Design History File (DHF)
Q: What are the common sources of design history file remediation?
Common sources include a non-compliant design control process and teams being unaware of design control requirements.
Verification & Validation Explained — A Practical Conversation with Aaron Joseph
Q: What is the significance of traceability in V&V?
Traceability is vital for answering questions on whether all requirements have been verified and for ensuring the integrity of testing across potentially complex projects with numerous requirements.
Verification & Validation Explained — A Practical Conversation with Aaron Joseph
Q: What are the common V&V fails?
The top issues include poor or unclear requirements, planning V&V too late, and overly complicated testing methods.
Verification & Validation Explained — A Practical Conversation with Aaron Joseph
Q: At which stage of the process should V&V be conducted?
V&V should be integrated throughout the entire product development cycle, from the beginning rather than only at the end.

Audience Metrics

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

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Gender Skew
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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 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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How many listeners does Medical Device made Easy Podcast get?

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What are the audience demographics for Medical Device made Easy Podcast?

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How many subscribers and views does Medical Device made Easy Podcast have?

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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 IdeaCast
4. TED Talks Daily
5. Chasing Life

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

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.

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.

Where can I see ratings and reviews for Medical Device made Easy Podcast?

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What guests have appeared on Medical Device made Easy Podcast?

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

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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