Medical Device made Easy Podcast Archiv
417 Episoden
1 Minute
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
The post What is changing with the new ISO 10993-1 version 2025 appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
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
The post From Zero to One: The journey of a CRO with Helene Quie appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
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
The post Medical Device News November 2025 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
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
The post Automatisation of your QA RA job with AI appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
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
The post US Government Shutdown – What FDA can still be doing? appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
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
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
1 Minute
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 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
1 Minute
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
The post Highlights from La Rentrée du DM 2025 appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
Medboard Europe Switzerland UK Magazine Events EasyIFU ROW Podcast Easy Medical Device Service Social Media to follow
The post Medical Device News OCTOBER 2025 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
The post Medical Device News OCTOBER 2025 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
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
The post Post-Market Surveillance for Software and AI Devices appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
The journey from a successful surgical career to the leadership of a medical company is far from ordinary. Yet for Prof. Marc Possover, this evolution felt like a natural extension […]
The post From Surgeon to CEO: Building NEUROGYN AG Professor Marc Possover’s Journey appeared first on Medical Device made Easy Podcast. hamza benafqir
The post From Surgeon to CEO: Building NEUROGYN AG Professor Marc Possover’s Journey appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
Cybersecurity in Medical Devices – A QA/RA Perspective Cybersecurity is often seen as an IT or engineering issue—but in reality, regulators and auditors turn to QA and Regulatory Affairs professionals […]
The post Cybersecurity in Medical Devices – What QA/RA Must Do Today appeared first on Medical Device made Easy Podcast. hamza benafqir
The post Cybersecurity in Medical Devices – What QA/RA Must Do Today appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
Medboard EUROPE UK Switzerland Magazine Podcast: REST OF THE WORLD
The post Medical Device News September 2025 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
The post Medical Device News September 2025 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
Artificial Intelligence is no longer just a buzzword — it’s already finding its way into Quality Assurance (QA) and Regulatory Affairs (RA) in the medical device industry. But what does […]
The post The good, bad and uglyof using AIfor QA RA Compliance appeared first on Medical Device made Easy Podcast. hamza benafqir
The post The good, bad and uglyof using AIfor QA RA Compliance appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
Managing Software Updates in Medical Devices: Best Practices & Pitfalls In the world of medical devices, software updates are never just technical tweaks—they directly impact patient safety, regulatory compliance, and […]
The post Medical Device Software Versioning appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post Medical Device Software Versioning appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
