Medical Device made Easy Podcast

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

From Zero to One: Mastering Client Collaboration in ConsultingStarting your consulting journey can feel overwhelming—finding clients, building trust, and delivering results all at once. In my conversation for the Medical […] The post From Zero to One How to collaborate with clients appeared first on Medical Device made Easy Podcast. hamza benafqir

Have you ever wondered what it’s really like to work as a medical device consultant or ISO 13485 auditor? In this episode of the Medical Device Made Easy Podcast, I […] The post From Zero to One: Becoming a Medical Device auditor appeared first on Medical Device made Easy Podcast. hamza benafqir

In our latest podcast, we dive deep into the recruitment world with Mitch, a founder and specialist recruiter in Quality Assurance & Regulatory Affairs (QA/RA). If you’re a hiring manager, […] The post From Zero to One – Should You Work with a QA/RA Recruiter? | Podcast Episode appeared first on Medical Device made Easy Podcast. hamza benafqir

Everything You Need to Know About EU Regulation 2025/1234 and the Future of eIFU for Medical Devices On July 16, 2025, a pivotal regulatory update—EU 2025/1234—comes into effect, expanding the […] The post Why Switch to eIFU? Top Regulatory & Operational Benefits Explained for Medical Device Manufacturers appeared first on Medical Device made Easy Podcast. hamza benafqir

Quality & Regulatory in MedTech – Interview with Pardeep Kaur Background: From IT in India to MedTech in Norway Day-to-Day as a QARA Manager First MedTech Role at Hy5Pro AS […] The post Quality & Regulatory in MedTech – Interview with Pardeep Kaur appeared first on Medical Device made Easy Podcast. hamza benafqir

Guest: Stefan Bolleininger Title: From Zero to One: Creating your Consulting Firm Logo: Be on Quality Telling the story behind Be on Quality, Sharing also the life of a CEO […] The post From Zero to One: Creating your Consulting Firm appeared first on Medical Device made Easy Podcast. hamza benafqir