Medical Device made Easy Podcast

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 AG Professor Marc Possover’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

Medboard: https://www.medboard.com/ EUROPE UK ROW Podcast The post Medical Device News JULY 2025 Regulatory Update appeared first on Medical Device made Easy Podcast . hamza benafqir

From Zero to One: SaaS Founder’s First Five Years with Ivan Perez Chamorro 🎧💡 In this exciting episode of the Easy Medical Device Podcast, we welcome Ivan Perez Chamorro, the […] The post From Zero to One: SaaS Founder’s First Five Years appeared first on Medical Device made Easy Podcast . hamza benafqir

🎙️ Risk Grading Gone Wrong: How to Fix Your Severity, Occurrence & Detection Strategy Before Your Notified Body Does 🩺 Risk Management mistakes that could cost you your certification! In […] The post Notified Bodies raise concern on Risk Grading appeared first on Medical Device made Easy Podcast . hamza benafqir

In this episode, Anindya Mookerjea will share with us his knowledge on Software Testing. We will review the basics and help you with being compliant to your projects. The post Software as a Medical Device: Beginner’s Guide to Testing & Validation appeared first on Medical Device made Easy Podcast . hamza benafqir

episode 339 Medical Device News JUNE 2025 Regulatory Update monir el azzouzi easy medical device The post Medical Device News JUNE 2025 Regulatory Update appeared first on Medical Device made Easy Podcast . hamza benafqir

Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson […] The post Trapped or Strategic? Changing Notified Bodies During MDR Transition appeared first on Medical Device made Easy Podcast . hamza benafqir

In this episode, Carmen Bellebna will share with us the journey of deepeye Medical to implement the EU AI act requirements in parallel with the EU MDR certification. The post How deepeye Medical overcame the AI ACT? appeared first on Medical Device made Easy Podcast . hamza benafqir

In this episode, Cecile van der Heijden will disclose all the secret of the EHDS or European Health Data Space law. The post Is EHDS dangerous for Medical Device manufacturers? appeared first on Medical Device made Easy Podcast . hamza benafqir

In this episode, Aouda Ouzza is helping us understand when the Regulatory Affairs person is needed during the design phase. The post When is Regulatory Affairs needed during Design?  appeared first on Medical Device made Easy Podcast . hamza benafqir