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Artwork for Easy Medical Device Podcast

Easy Medical Device Podcast

easymedicaldevice
Medical Devices
Regulatory Affairs
Artificial Intelligence
Medical Device Regulation
ISO 13485
Risk Management
FDA
Regulatory Compliance
Quality Management System
Quality and Regulatory Affairs
Clinical Evaluation
Quality Management Systems
Notified Bodies
AI Act
EU MDR
Quality Assurance
Medboard
MDR
IEC 60601
Quality Management

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

PublishesWeeklyEpisodes421Founded8 years ago
Number of ListenersCategories
EntrepreneurshipBusiness

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Artwork for Easy Medical Device Podcast

Latest Episodes

From Virtual Reality Innovation to Medical Device Compliance: The Story of Pedro Thomaz and Revert

Many healthcare technology startups begin with a simple objective: develop an innovative solution that addresses a real problem.

They focus on techno... more

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Exploring AI-Assisted Clinical Evaluation with Ethan Drower from CiteMed

Artificial Intelligence is changing how medical device companies approach documentation, information management, and regulatory activities.

One area attracting increasing atte... more

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Small Business, Smart Start: AI Without Complex Infrastructure

Artificial Intelligence is creating new opportunities for businesses to improve productivity, simplify workflows, and reduce repetitive administrative work.

However, for many small medi... more

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October brings another important round of regulatory developments for the medical device and IVD industry. From updated IVD classification guidance in Europe and potential changes to the UK medical device licensing framework, to new FDA expectations ... more

YouTube

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Recent Guests

Ethan Drower
CEO and co-founder of CiteMed with a software engineering background.
CiteMed
Episode: Can AI Really Write Your Clinical Evaluation Report?
Helder Conceicao
Former Johnson & Johnson leader with experience in service engineering, business processes, digital products, and AI adoption.
Heco Nexus
Episode: AI Agents for Your Medical Device Business: Where Do You Start?
Shreya Sridhar
Systems engineer at Medtronic
Medtronic
Episode: Vertical Slicing for Complex SaMD Development
Chiratana Pot
Product Management at Enlil
Enlil
Episode: The Audit Readiness Myth: Why Most Startups Aren't As Prepared As They Think
Joanna Nathan
CEO of Prana Surgery
Prana Surgery
Episode: The FDA Clearance Journey: What Nobody Tells Medical Device Startups
Mathangi Srinivasan
Quality Assurance Manager at Abbott Vascular, industry veteran in QA and manufacturing
Abbott Vascular
Episode: FEEDBACK AFTER 3 MONTHS OF THE NEW FDA QMSR IS IN PLACE
Karandeep Badwal
Founder of QRA Medical and the MedTech Podcast
QRA Medical; MedTech Podcast
Episode: How can a proper Intended Use save your device?
Sandy Wright
Head of Devices at Scarlet, medical doctor by background
Scarlet
Episode: The Hidden Costs of UDI Mistakes in Medical Devices
Osman El-Koubani
Clinical engineer at Scarlet, specializing in software as a medical device and post-market surveillance
Scarlet
Episode: Life After CE Marking: Why AI Medical Devices Need Continuous Monitoring

Host

Monir El Azzouzi
Host and medical device quality/regulatory affairs expert; leads discussions on regulatory strategy, quality systems, and post-market obligations.

Reviews

4.8 out of 5 stars from 107 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 Kingdom3 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 States6 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 States7 years ago

Listeners Say

Key themes from listener reviews, highlighting what works and what could be improved about the show.

Opinions consistently highlight practical, regulatory-focused guidance.
Audience notes the host's depth in medical device compliance and industry knowledge.
Listeners praise clear explanations of complex topics like QMSR and MDR/IVDR.
Guests are valued for real-world experience and actionable takeaways.

Chart Rankings

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

Talking Points

Recent interactions between the hosts and their guests.

Can AI Really Write Your Clinical Evaluation Report?
Q: Should I go and check all those sources again and verify that, yes, what is written on this is fine?
Yes. Drower warns that AI can fabricate citations and recommends a structured literature database, reproducible methods, and systematic records of screening decisions. AI can assist with screening and extraction, but evaluators must verify the evidence and outputs.
Can AI Really Write Your Clinical Evaluation Report?
Q: Do you think now I can use AI and create one and everything is fine?
No. Drower says AI cannot compensate for lacking clinical evaluation knowledge, and unstructured attempts to draft entire sections may take longer to review and correct. AI can help users learn section mechanics and work through specific tasks, but qualified people must assess the results.
AI Agents for Your Medical Device Business: Where Do You Start?
Q: What are some useful starting points for AI in medical device companies, such as quality and regulatory affairs, documentation, or field service?
Start with low-risk work such as drafting documents, comparing revisions, and checking documents against checklists and regulations. For higher-risk decisions, use AI to challenge decisions or compare options, and require supporting sources and human review.
AI Agents for Your Medical Device Business: Where Do You Start?
Q: How would you explain the difference between AI chats and AI agents to somebody who is just starting with AI?
With chat tools, users ask questions but still do the work themselves. Agents are given an objective, context, and access to tools so they can carry out tasks, ask clarifying questions, and propose a plan for human review.
Vertical Slicing for Complex SaMD Development
Q: What practical advice would you give teams wanting to try vertical slicing on their next feature?
Start with the next upcoming feature, map all the required components, involve the right cross-functional people, document the decisions for that slice, and run an end-to-end review to identify dependencies and risks early before scaling to more features.

Audience Metrics

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

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Frequently Asked Questions About Easy Medical Device Podcast

What is Easy Medical Device Podcast about and what kind of topics does it cover?

This show concentrates on navigating medical device regulation, quality systems, and post-market obligations with a focus on practical, real-world guidance. Across episodes, listeners get deep dives into FDA QMSR transitions, risk management, audit readiness, EU MDR/IVDR updates, and the evolving role of data-driven monitoring for AI-enabled devices. Guests include regulators, industry practitioners, and technology leaders who share actionable steps, templates, and lessons from live projects. A standout aspect is the ongoing emphasis on cross-functional collaboration, evidence-based decisions, and early regulator engagement to prevent costly missteps. The format blends expert interviews with host-led analysis and periodic sponsor segments t... more

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How many listeners does Easy Medical Device Podcast get?

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Which podcasts are similar to Easy Medical Device Podcast?

These podcasts share a similar audience with Easy Medical Device Podcast:

1. Global Medical Device Podcast powered by Greenlight Guru
2. The Diary Of A CEO with Steven Bartlett
3. The Rest Is Politics
4. The Rest Is History
5. Rear Vision — How History Shaped Today

How many episodes of Easy Medical Device Podcast are there?

Easy Medical Device Podcast launched 8 years ago and published 421 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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What guests have appeared on Easy Medical Device Podcast?

Recent guests on Easy Medical Device Podcast include:

1. Ethan Drower
2. Helder Conceicao
3. Shreya Sridhar
4. Chiratana Pot
5. Joanna Nathan
6. Mathangi Srinivasan
7. Karandeep Badwal
8. Sandy Wright

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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