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Listen Medical Device Regulation and Standards

Location:

France

Description:

Listen Medical Device Regulation and Standards

Language:

English


Episodes
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From Zero to One: SaaS Founder’s First Five Years

6/25/2025
From Zero to One: SaaS Founder’s First Five Years with Ivan Perez Chamorro 🎧💡 In this exciting episode of the Easy Medical Device Podcast, we welcome Ivan Perez Chamorro, the […] The post From Zero to One: SaaS Founder’s First Five Years appeared first on Medical Device made Easy Podcast. hamza benafqir

Duration:01:03:22

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Notified Bodies raise concern on Risk Grading

6/18/2025
🎙️ Risk Grading Gone Wrong: How to Fix Your Severity, Occurrence & Detection Strategy Before Your Notified Body Does 🩺 Risk Management mistakes that could cost you your certification! In […] The post Notified Bodies raise concern on Risk Grading appeared first on Medical Device made Easy Podcast. hamza benafqir

Duration:00:20:54

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Software as a Medical Device: Beginner’s Guide to Testing & Validation

6/11/2025
In this episode, Anindya Mookerjea will share with us his knowledge on Software Testing. We will review the basics and help you with being compliant to your projects. The post Software as a Medical Device: Beginner’s Guide to Testing & Validation appeared first on Medical Device made Easy Podcast. hamza benafqir

Duration:00:37:01

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Medical Device News JUNE 2025 Regulatory Update

6/4/2025
episode 339 Medical Device News JUNE 2025 Regulatory Update monir el azzouzi easy medical device The post Medical Device News JUNE 2025 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

Duration:00:29:36

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Trapped or Strategic? Changing Notified Bodies During MDR Transition

5/28/2025
Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson […] The post Trapped or Strategic? Changing Notified Bodies During MDR Transition appeared first on Medical Device made Easy Podcast. hamza benafqir

Duration:00:32:19

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How deepeye Medical overcame the AI ACT?

5/21/2025
In this episode, Carmen Bellebna will share with us the journey of deepeye Medical to implement the EU AI act requirements in parallel with the EU MDR certification. The post How deepeye Medical overcame the AI ACT? appeared first on Medical Device made Easy Podcast. hamza benafqir
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Is EHDS dangerous for Medical Device manufacturers?

5/14/2025
In this episode, Cecile van der Heijden will disclose all the secret of the EHDS or European Health Data Space law. The post Is EHDS dangerous for Medical Device manufacturers? appeared first on Medical Device made Easy Podcast. hamza benafqir
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When is Regulatory Affairs needed during Design?

5/7/2025
In this episode, Aouda Ouzza is helping us understand when the Regulatory Affairs person is needed during the design phase. The post When is Regulatory Affairs needed during Design? appeared first on Medical Device made Easy Podcast. hamza benafqir
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What is the new UK Post-Market Surveillance Requirements?

4/30/2025
In this episode, Claire Dyson will clarify to us what is the new PMS requirements from UK MHRA. The post What is the new UK Post-Market Surveillance Requirements? appeared first on Medical Device made Easy Podcast. hamza benafqir
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How to register your Medical Device in Malaysia?

4/23/2025
In this episode, Adam Isaacs Rae is helping us to register our Medical Devices in Malaysia. We will review the requirements for it. The post How to register your Medical Device in Malaysia? appeared first on Medical Device made Easy Podcast. hamza benafqir
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Should you quit your job to become a consultant?

4/16/2025
In this episode, Yassine Bader will explain to you the advantage or the risk of quitting your permanent job to become a consultant. The post Should you quit your job to become a consultant? appeared first on Medical Device made Easy Podcast. hamza benafqir
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How to satisfy Cybersecurity for FDA and EU?

4/10/2025
In this episode, Cyrille Michaud from MD101 will explain us how to prepare for Cybersecurity compliance for your medical device. The post How to satisfy Cybersecurity for FDA and EU? appeared first on Medical Device made Easy Podcast. hamza benafqir
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Medical Device News April 2025 Regulatory Update

4/3/2025
Sponsor: Medboard Europe Registration ROW Podcast Social Media to follow The post Medical Device News April 2025 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
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What are the TOP 3 FDA inspection issues?

3/20/2025
In this episode, Darrin Carlson will explain to us what are the main issues that are discovered during FDA inspections and how to correct them. The post What are the TOP 3 FDA inspection issues? appeared first on Medical Device made Easy Podcast. hamza benafqir
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Medical Device News March 2025 Regulatory Update

3/12/2025
Medical Device News January 2025 Regulatory Update The post Medical Device News March 2025 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
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How to avoid Clinical Investigation for your Device?

3/5/2025
In this episode, Hatem Rabeh will explain to us what are Clinical Data and also if there is a chance for you to avoid Clinical Investigations The post How to avoid Clinical Investigation for your Device? appeared first on Medical Device made Easy Podcast. hamza benafqir

Duration:00:48:36

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FDA: Advantage of the Breakthrough Device Program

2/26/2025
In this episode, Michelle Lott will walk us through the Breakthrough Device Program created by the FDA. Who can benefit from it? And what are the benefits? The post FDA: Advantage of the Breakthrough Device Program appeared first on Medical Device made Easy Podcast. hamza benafqir

Duration:00:25:59

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How and Who to build your Risk Management File?

2/19/2025
In this episode, Bijan Elahi will share with us the methodology you should follow to start your Risk Management Project The post How and Who to build your Risk Management File? appeared first on Medical Device made Easy Podcast. hamza benafqir

Duration:00:26:46

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The good, the bad and the ugly of certification bodies

2/12/2025
In this episode, Mark Rogovoi will share his experience with Certification Bodies. The post The good, the bad and the ugly of certification bodies appeared first on Medical Device made Easy Podcast. hamza benafqir

Duration:00:35:46

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Medical Device News January 2025 Regulatory Update

2/5/2025
Medboard EU Training Rest of the World: Podcast The post Medical Device News January 2025 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

Duration:00:26:54