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Artwork for Medical Device made Easy Podcast

Medical Device made Easy Podcast

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

PublishesWeeklyEpisodes407Founded8 years ago
Number of ListenersCategories
EntrepreneurshipBusiness

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Artwork for Medical Device made Easy Podcast

Latest Episodes

Many medical device startups assume they're audit ready because they have documented procedures, completed templates, and a Quality Management System in place.

However, successful audits require much more than organized documentation.

In this episo... more

YouTube

For many medical device startups, obtaining FDA clearance seems like a clear, linear process.

Identify a predicate device.

Prepare your documentation.

Submit your application.

Wait for clearance.

In reality, the journey is rarely that simple.

I... more

YouTube

For many medical device companies, a successful audit is seen as the ultimate proof that their Quality Management System is performing well.

Few or no findings.

Positive feedback from auditors.

Management celebrates.

But does passing an audit rea... more

YouTube

Sponsor

Medboard: www.medboard.com/

Europe

Well-Established Technologies - Publication of the Delegated act: ec.europa.eu/newsroom/sante/newsletter-archives/77013

2 Delegated acts:

Class III and implantables: eur-lex.euro... more

YouTube

Key Facts

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Recent Guests

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
Camille Petri
Principal Scientist at Scarlet; lead authority on clinical evaluation and AI/machine learning in devices
Scarlet
Episode: AI Medical Devices: What Notified Bodies Really Look For
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

Host

Monir El Azzouzi
Host of the medical device regulatory-focused show and expert in quality and regulatory affairs.

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 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 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.

High-quality interviews with industry experts and sponsors.
Excellent resource for EU/UK MDR and global markets.
Clear, practical regulatory guidance that's easy to apply.

Chart Rankings

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

Talking Points

Recent interactions between the hosts and their guests.

The FDA Clearance Journey: What Nobody Tells Medical Device Startups
Q: How did you handle the predicate and labeling strategy for the 510(k) submission?
We explored various predicates with input from our regulatory consultants, and FDA indicated one predicate wasn't the right fit; we then recalibrated our case for substantial equivalence with a different predicate.
The FDA Clearance Journey: What Nobody Tells Medical Device Startups
Q: What was your biggest learning about engaging with the FDA early in the process?
Early and frequent pre-submission conversations with FDA, guided by a knowledgeable regulatory consultant, help shape a stronger submission and align expectations, reducing risk and time toward clearance.
The FDA Clearance Journey: What Nobody Tells Medical Device Startups
Q: Can you introduce yourself and tell us what Prana Surgery does?
I'm the CEO and co-founder of Prana Surgical, a Houston-based startup focused on minimally invasive interventions for lung cancer nodules, leveraging a device to surgically intervene and reduce the barrier to treatment.
The Audit Readiness Myth: Why Most Startups Aren't As Prepared As They Think
Q: Is there a way for listeners to see a demo of the tool and understand how it works in practice?
Yes, they offer demos and demo videos, and show slides via a show notes link for listeners to review the tool and potentially request a live demonstration.
The Audit Readiness Myth: Why Most Startups Aren't As Prepared As They Think
Q: What solutions does Enlil offer to help startups become audit-ready and to manage the full regulatory lifecycle?
Enlil provides a unified data platform that connects requirements, tests, risk, suppliers, and documentation, with features like Milestone View and AI-assisted surface of missing or out-of-date items to maintain continuous compliance and streamline audits.

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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 show targets professionals navigating medical device regulations, quality systems, and market access. Episodes feature regulatory updates, practical guidance on EU MDR/IVDR, QMS implementation, AI in medical devices, post-market monitoring, and case studies from industry experts. A notable pattern is deep technical discussions led by a seasoned regulator/consultant, with guests from sponsor organizations and consulting firms who illuminate real-world pathways to compliant product launches. Listeners can expect actionable takeaways, step-by-step guidance, and insights into interfacing with notified bodies and regulators, making it valuable for advanced practitioners and teams preparing filings or looking to accelerate global market acce... more

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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 Combinate - Drugs + Devices
3. Let's Combinate - Drugs + Devices
4. Big Swings Only
5. Economist Podcasts

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

Medical Device made Easy Podcast launched 8 years ago and published 407 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 Medical Device made Easy Podcast?

Recent guests on Medical Device made Easy Podcast include:

1. Chiratana Pot
2. Joanna Nathan
3. Mathangi Srinivasan
4. Karandeep Badwal
5. Sandy Wright
6. Osman El-Koubani
7. Camille Petri
8. Stephanie Grassmann

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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