Rephonic
Artwork for Medical Device made Easy Podcast

Medical Device made Easy Podcast

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

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

PublishesWeeklyEpisodes386Founded7 years ago
Number of ListenersCategories
BusinessEntrepreneurship

Listen to this Podcast

Artwork for Medical Device made Easy Podcast

Latest Episodes

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

In Software as a Medical Device (SaMD), defect management is far more than tracking bugs. It is a structured, risk-driven process that directly impacts patient safety, regulatory compliance, and product lifecycle control.

This article (and podcast e... more

YouTube

SPONSOR

Medboard: www.medboard.com/

EUROPE

New Harmonization Standards - Implementing Decision 2026/193:

eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202600193

Neurosurgical implants

EN ISO 14155:2020 on clinical inves... more

YouTube

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

Key Facts

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

Similar Podcasts

People also subscribe to these shows.

Global Medical Device Podcast powered by Greenlight Guru
Global Medical Device Podcast powered by Greenlight GuruGreenlight Guru + Medical Device Entrepreneurs
Let's Talk Risk! with Dr. Naveen Agarwal
Let's Talk Risk! with Dr. Naveen AgarwalCasual and informal conversations about practical aspects of medical device risk management.
The Daily
The DailyThe New York Times
Pod Save America
Pod Save AmericaPod Save America

Recent Guests

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
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?

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.

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.
Defect Management in SaMD — From Chaos to Control
Q: Is there any, if I can say advantage or maybe inconvenient, to mix that with CAPA or it should be really separate from the CAPA system?
Let's keep these two separate because not every defect leads to a CAPA unless there's a trend that needs to be analyzed.

Audience Metrics

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

Listeners per Episode
Gender Skew
Location
Interests
Professions
Age Range
Household Income
Social Media Reach

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.

Where can I find podcast stats for Medical Device made Easy Podcast?

Rephonic provides a wide range of podcast stats for Medical Device made Easy Podcast. We scanned the web and collated all of the information that we could find in our comprehensive podcast database. See how many people listen to Medical Device made Easy Podcast and access YouTube viewership numbers, download stats, audience demographics, chart rankings, ratings, reviews and more.

How many listeners does Medical Device made Easy Podcast get?

Rephonic provides a full set of podcast information for three million podcasts, including the number of listeners. View further listenership figures for Medical Device made Easy Podcast, including podcast download numbers and subscriber numbers, so you can make better decisions about which podcasts to sponsor or be a guest on. You will need to upgrade your account to access this premium data.

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

Rephonic provides comprehensive predictive audience data for Medical Device made Easy Podcast, including gender skew, age, country, political leaning, income, professions, education level, and interests. You can access these listener demographics by upgrading your account.

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

To see how many followers or subscribers Medical Device made Easy Podcast has on Spotify and other platforms such as Castbox and Podcast Addict, simply upgrade your account. You'll also find viewership figures for their YouTube channel if they have one.

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. The Daily
4. Up First from NPR
5. Pod Save America

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

Medical Device made Easy Podcast launched 7 years ago and published 386 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?

Rephonic pulls ratings and reviews for Medical Device made Easy Podcast from multiple sources, including Spotify, Apple Podcasts, Castbox, and Podcast Addict.

View all the reviews in one place instead of visiting each platform individually and use this information to decide if a show is worth pitching or not.

How do I access podcast episode transcripts for Medical Device made Easy Podcast?

Rephonic provides full transcripts for episodes of Medical Device made Easy Podcast. Search within each transcript for your keywords, whether they be topics, brands or people, and figure out if it's worth pitching as a guest or sponsor. You can even set-up alerts to get notified when your keywords are mentioned.

What guests have appeared on Medical Device made Easy Podcast?

Recent guests on Medical Device made Easy Podcast include:

1. Leo Eisner
2. Anindya Mukherjee
3. Simon Foeger
4. Aaron Joseph
5. Florian Tolkmitt
6. Marina Daineko
7. Helene Quie
8. Hatem Rabeh

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.

Find and pitch the right podcasts

We help savvy brands, marketers and PR professionals to find the right podcasts for any topic or niche. Get the data and contacts you need to pitch podcasts at scale and turn listeners into customers.
Try it free for 7 days