Medical Device made Easy Podcast

The long-awaited revision of ISO 10993-1 is almost here – and the MedTech community is full of questions.Will we need to retest everything?Is this a complete game-changer, or just an […]The post What is changing with the new ISO 10993-1 version 2025 appeared first on Medical Device made Easy Podcast. hamza benafqir

In this long-form interview, Helene Quie, founder of Qmed Consulting, shares an inside look at nearly 20 years of experience in clinical and regulatory consulting for medical devices. This article […]The post From Zero to One: The journey of a CRO with Helene Quie appeared first on Medical Device made Easy Podcast. hamza benafqir

MedBoard EU Service Magazine ROW PODCAST Social Media to followThe post Medical Device News November 2025 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

Artificial Intelligence is reshaping the world of Quality and Regulatory Affairs.In this podcast episode, Hatem Rabeh joins to demystify how AI can be used — and where it must be […]The post Automatisation of your QA RA job with AI appeared first on Medical Device made Easy Podcast. hamza benafqir

US Government Shutdown – What the FDA Can Still Be Doing? When the U.S. government experiences a shutdown, the consequences ripple across every industry — but for medical device manufacturers, […]The post US Government Shutdown – What FDA can still be doing? appeared first on Medical Device made Easy Podcast. hamza benafqir

Real-World Evidence (RWE) is transforming how regulators evaluate medical devices — but many manufacturers still struggle to use it correctly. In this episode, we break down what RWE really means, […]The post Real-World Evidence (RWE): How to Use It Right for FDA and EU MDR Compliance appeared first on Medical Device made Easy Podcast. hamza benafqir

Since the implementation of EU MDR 2017/745, clinical evidence has become one of the biggest challenges for medical device manufacturers — and a major source of Notified Body nonconformities. This […]The post Clinical Evidence under EU MDR – Why So Many Dossiers Fail (and How to Fix It) appeared first on Medical Device made Easy Podcast. hamza benafqir

The La Rentrée du DM 2025 conference brought together regulators, manufacturers, and industry experts to discuss the evolving landscape of European and global medical device regulation. Main themes included: The […]The post Highlights from La Rentrée du DM 2025 appeared first on Medical Device made Easy Podcast. hamza benafqir

Medboard Europe Switzerland UK Magazine Events EasyIFU ROW Podcast Easy Medical Device Service Social Media to followThe post Medical Device News OCTOBER 2025 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

Post-Market Surveillance for Software & AI Devices – A QA/RA Guide Software evolves with updates. AI models may even change with real-world data. That makes Post-Market Surveillance (PMS) for digital […]The post Post-Market Surveillance for Software and AI Devices appeared first on Medical Device made Easy Podcast. hamza benafqir