Medical Device made Easy Podcast

Listen Medical Device Regulation and Standards

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What is the new UK Post-Market Surveillance Requirements? 01.05.2025

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

How to register your Medical Device in Malaysia?  24.04.2025

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

Should you quit your job to become a consultant? 16.04.2025

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

How to satisfy Cybersecurity for FDA and EU? 10.04.2025

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

Medical Device News April 2025 Regulatory Update 04.04.2025

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

What are the TOP 3 FDA inspection issues? 20.03.2025

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

Medical Device News March 2025 Regulatory Update 13.03.2025

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

How to avoid Clinical Investigation for your Device?  06.03.2025

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

FDA: Advantage of the Breakthrough Device Program   27.02.2025

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

How and Who to build your Risk Management File? 20.02.2025

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

The good, the bad and the ugly of certification bodies  13.02.2025

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

Medical Device News January 2025 Regulatory Update 06.02.2025

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

6 Tips to Grow as a QA RA Manager  30.01.2025

In this episode, I will give you some advice on how to grow as a QA RA Manager. The post 6 Tips to Grow as a QA RA Manager  appeared first on Medical Device made Easy Podcast . hamza benafqir

TOP 5 common NCs on an ISO 13485 audit  23.01.2025

In this episode, Adam Isaac Rae will share with us is TOP 5 common NCs during an ISO 13485 audit. The post TOP 5 common NCs on an ISO 13485 audit  appeared first on Medical Device made Easy Podcast . hamza benafqir

How to perform your PMS for a Drug-Device Combination? 16.01.2025

In this episode, Dr. Joan D’Souza will help us to do our PMS the right way when we have to deal with a Drug-Device Combination. The post How to perform your PMS for a Drug-Device Combination? appeared first on Medical Device made Easy Podcast . hamza benafqir

How to register a Medical Device in South Africa?  09.01.2025

In this episode, Khanyisile Nkuku will share with us the way companies can register an medical device in South Africa. The post How to register a Medical Device in South Africa?  appeared first on Medical Device made Easy Podcast . hamza benafqir

Medica: AI & MDR FLIP THE COIN 02.01.2025

Stefan bolleininger will share with us information regarding Artificial intelligence and MDR. This presentation happened during Medica 2024. So if you have any questions you can ask ok the comments. […] The post Medica: AI & MDR FLIP THE COIN appeared first on Medical Device made Easy Podcast . hamza benafqir

Easy Medical Device Great Summary 2024 26.12.2024

In this episode, Monir El Azzouzi will summarize 2024 for Easy Medical Device and share projects for 2025. The post Easy Medical Device Great Summary 2024 appeared first on Medical Device made Easy Podcast . hamza benafqir

What are the major pitfalls of Startups in Medical Devices? 19.12.2024

In this episode, Adnan Ashfaq will share with us the major pitfalls he experienced when dealing with Medical Device startups. The post What are the major pitfalls of Startups in Medical Devices? appeared first on Medical Device made Easy Podcast . hamza benafqir

Medical Device News December 2024 Regulatory Update 12.12.2024

MEDBOARD: https://www.medboard.com/ EUROPE SMARTEYE EVENTS TRAINING ROW • Webinar January 14, 2025 – https://www.fda.gov/medical-devices/cdrhnew-news-andupdates/webinar-final-guidance-marketing-submission-recommendations-predetermined-change-control-plan?utm_source=FDALinkedin PODCAST Social Media to follow The post Medical Device News December 2024 Regulatory Update appeared first on Medica...

PCCP – The Magic tool for SaMD in the US? 05.12.2024

In this episode, Maria Diez from CMGMedDev is explaining to us the PCCP tool for SaMD and why it can help a lot. The post PCCP – The Magic tool for SaMD in the US? appeared first on Medical Device made Easy Podcast . hamza benafqir

IEC 60601-1-8 How to test your Medical Device alarms? 28.11.2024

: In this episode, Beat Keller from SMDC in Switzerland will help us to setup the right tests for your alarm systems. And you’ll see that it is not so obvious. The post IEC 60601-1-8 How to test your Medical Device alarms? appeared first on Medical Device made Easy Podcast . hamza benafqir

How to build the perfect Quality Management System? 21.11.2024

In this episode, Monir El Azzouzi will help you build the perfect Quality Management System. He will give you his recipe to start the creation of a QMS and show you step by step what you should do. The post How to build the perfect Quality Management System? appeared first on Medical Device made Easy Podcast . hamza benafqir

Is FMEA bad for your Risk Management?  14.11.2024

Podcast: Is FMEA bad for your Risk Management? With Monir El Azzouzi and Rod Beuzeval The post Is FMEA bad for your Risk Management?  appeared first on Medical Device made Easy Podcast . hamza benafqir

How MDR and IVDR code can save you money? 07.11.2024

In this episode, Stefan Bolleininger will explain you can save money on your MDR or IVDR submission just by choosing the right MDR or IVDR code and by following some of his advice. The post How MDR and IVDR code can save you money? appeared first on Medical Device made Easy Podcast . hamza benafqir

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