Medical Device made Easy Podcast
1) From Surgeon to CEO: Building NEUROGYN AGProfessor MarcPossover’s Journey
From Surgeon to CEO: Prof. Marc Possover’s Inspiring Journey in Medical Innovation The journey from a successful surgical career to the leadership of a medical company is far from ordinary. Yet for Pr...Show More
2) Medical Device News September 2025 Regulatory Update
Medboard EUROPE Guidance on the implementation of the Master UDI-DI - MDCG 2024-14 - rev.1 : https://health.ec.europa.eu/document/download/c8c6cca5-460e-410e-a325-be08bfc7dea6_en?filename=mdcg_2024-...Show More
3) From Zero to One – Should You Work with a QA/RA Recruiter? | Podcast Episode
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, candidate, ...Show More
4) Why Switch to eIFU? Top Regulatory & Operational Benefits Explained for Medical Device Manufacturers
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 use of ...Show More
5) Quality & Regulatory in MedTech – Interview with Pardeep Kaur
Background: From IT in India to MedTech in Norway You have a pretty fascinating background – you studied computer applications/IT back in India and now you’re a Quality/Regulatory Manager in the Norw...Show More
6) From Zero to One: Creating your Consulting Firm
Guest: Stefan Bolleininger Title: From Zero to One: Creating your Consulting Firm Logo: Be on Quality Telling the story behind Be on Quality, the challenges for you, the way you did grow the b...Show More
7) Notified Bodies raise concern on Risk Grading
🎙️ 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 this episod...Show More
8) Software as a Medical Device: Beginner’s Guide to Testing & Validation
■Learn how to turn user needs into clear, beginner-friendly test plans for Software as a Medical Device (SaMD). In this episode, we break down the essentials of SaMD validation—no PhD required! We cov...Show More
9) Trapped or Strategic? Changing Notified Bodies During MDR Transition
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 a...Show More
10) How deepeye Medical overcame the AI ACT?
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. We will review first what is the A...Show More