What is changing with the new ISO 10993-1 version 2025
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...
27 Marras 20250s
From Zero to One: The journey of a CRO with Helene Quie
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 […]...
20 Marras 20250s
Medical Device News November 2025 Regulatory Update
MedBoard EU Service Magazine ROW PODCAST Social Media to follow The post Medical Device News November 2025 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
12 Marras 20250s
Automatisation of your QA RA job with AI
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 Automati...
5 Marras 20250s
US Government Shutdown – What FDA can still be doing?
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...
30 Loka 20250s
Real-World Evidence (RWE): How to Use It Right for FDA and EU MDR Compliance
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, […]...
23 Loka 20250s
Clinical Evidence under EU MDR – Why So Many Dossiers Fail (and How to Fix It)
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 […]...
16 Loka 20250s
Highlights from La Rentrée du DM 2025
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 in...
9 Loka 20250s
