Medical Device made Easy Podcast

As the year closes, this special podcast episode offers a comprehensive overview of what happened at Easy Medical Device in 2025 and the key priorities shaping 2026. The episode reflects […] The post Last Podcast of the Year – Easy Medical Device | Year in Review & What’s Next appeared first on Medical Device made Easy Podcast. hamza benafqir

The European medical device sector is a vital pillar of healthcare innovation, employing over 930,000 people and representing a market of approximately €170 billion. However, since the implementation of MDR […] The post Simplifying EU Medical Device Regulations: Understanding the 2025 Proposal appeared first on Medical Device made Easy Podcast. hamza benafqir

Clinical Evaluation has become one of the most critical — and challenging — domains under the EU MDR. But how does one build real expertise in this field? In this […] The post From Engineer to Clinical Evaluation Expert – The Journey of Florian Tolkmitt appeared first on Medical Device made Easy Podcast. hamza benafqir

Medboard Europe UK Standard EasyIFU Rest of the World Argentina Canada Brazil: Podcast Podcast Nostalgia – Let’s review previous podcasts Social Media to follow The post Medical Device News DECEMBER 2025 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

Becoming a Lead Auditor is one of the most valuable career steps for quality and regulatory professionals in the MedTech sector. Lead Auditors play a critical role in evaluating QMS […] The post How to become a LEAD AUDITOR made Easy appeared first on Medical Device made Easy Podcast. hamza benafqir

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 follow The 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 follow The 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

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 AGProfessor MarcPossover’s Journey appeared first on Medical Device made Easy Podcast. hamza benafqir

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

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

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

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