All episodes
Unannounced Notified Body Audit: What If Your Quality Manager Isn’t There?
Medical Device Regulatory Update – November 2026
We Didn’t Know We Needed to Be a Medical Device” – Our Journey to CE Marking
Can AI Really Write Your Clinical Evaluation Report?
AI Agents for Your Medical Device Business: Where Do You Start?
Medical Device Regulatory Update – October 2026
AI Is Already Inside Your QMS — But Is It Under Control?
Vertical Slicing for Complex SaMD Development
Why Management Doesn’t Listen to Quality—and How to Change That
Your Technical Documentation Has All the Documents… So Why Isn’t It Ready?
Medical Device Regulatory Update: July & August 2026
From Verification & Validation to Global Market Access | V&V, DHF & IMDRF
Regulatory Strategy & Market Access | Intended Use & Master UDI-DI
Building a Strong Quality Management System: From Documentation to Real Compliance
Quality & Compliance: Building Stronger Medical Device Quality Systems
Your Risk Management File Is Probably Fiction
The Audit Readiness Myth: Why Most Startups Aren’t As Prepared As They Think
The FDA Clearance Journey: What Nobody Tells Medical Device Startups
The Audit Went Perfectly… So Why Are We Still in Trouble?
Medical Device News July 2026 Regulatory Update
“We’ve Never Had a Complaint” — The Most Dangerous Sentence in Medical Devices
NC vs CAPA: Are You Opening the Wrong Records?
Best of „AI CE marking“
Medical Device News June 2026 Regulatory Update
FEEDBACK AFTER 3 MONTHS OF THE NEW FDA QMSR IS IN PLACE
How can a proper Intended Use save your device?
Medical Device News May 2026 Regulatory Update
Can You Certify an LLM-Driven Medical Device?
Master UDI-DI: The New Layer Many MedTech Companies Don’t Understand
Life After CE Marking: Why AI Medical Devices Need Continuous Monitoring
The Fake QMS Problem: Why Your ISO 13485 System Will Fail an Audit
AI Medical Devices: What Notified Bodies Really Look For
Medical Device News APRIL 2026 Regulatory Update
These 3 podcasts will change how you see MedTech
EUDAMED Deadline 2026 – 7 Steps Every MedTech Company Must Prepare
Medical Device News March 2026 Regulatory Update
IMDRF & Regulatory Reliance Explained: The Future of Global Medical Device Approvals
IEC 60601 – From 2nd to 4th Edition: What Manufacturers Must Know
Defect Management in SaMD — From Chaos to Control
Medical Device News February 2026 Regulatory Update
Validation & Supplier Management in MedTech
QMSR Is Coming: Why FDA Inspections Will Change Completely in 2026
How to Remediate a Design History File (DHF)
Medical Device News January 2026 Regulatory Update
Verification & Validation Explained — A Practical Conversation with Aaron Joseph
Last Podcast of the Year – Easy Medical Device | Year in Review & What’s Next
Simplifying EU Medical Device Regulations: Understanding the 2025 Proposal
From Engineer to Clinical Evaluation Expert – The Journey of Florian Tolkmitt
Medical Device News DECEMBER 2025 Regulatory Update
How to become a LEAD AUDITOR made Easy
What is changing with the new ISO 10993-1 version 2025
From Zero to One: The journey of a CRO with Helene Quie
Medical Device News November 2025 Regulatory Update
Automatisation of your QA RA job with AI
US Government Shutdown – What FDA can still be doing?
Real-World Evidence (RWE): How to Use It Right for FDA and EU MDR Compliance
Clinical Evidence under EU MDR – Why So Many Dossiers Fail (and How to Fix It)
Highlights from La Rentrée du DM 2025
Medical Device News OCTOBER 2025 Regulatory Update
Post-Market Surveillance for Software and AI Devices
From Surgeon to CEO: Building NEUROGYN AG Professor Marc Possover’s Journey
Cybersecurity in Medical Devices – What QA/RA Must Do Today
Medical Device News September 2025 Regulatory Update
The good, bad and uglyof using AIfor QA RA Compliance
Medical Device Software Versioning
From Zero to One How to collaborate with clients
From Zero to One: Becoming a Medical Device auditor
From Zero to One – Should You Work with a QA/RA Recruiter? | Podcast Episode
Why Switch to eIFU? Top Regulatory & Operational Benefits Explained for Medical Device Manufacturers
Quality & Regulatory in MedTech – Interview with Pardeep Kaur
From Zero to One: Creating your Consulting Firm
Medical Device News JULY 2025 Regulatory Update
From Zero to One: SaaS Founder’s First Five Years
Notified Bodies raise concern on Risk Grading
Software as a Medical Device: Beginner’s Guide to Testing & Validation
Medical Device News JUNE 2025 Regulatory Update
Trapped or Strategic? Changing Notified Bodies During MDR Transition
How deepeye Medical overcame the AI ACT?
Is EHDS dangerous for Medical Device manufacturers?
When is Regulatory Affairs needed during Design?
What is the new UK Post-Market Surveillance Requirements?
How to register your Medical Device in Malaysia?
Should you quit your job to become a consultant?
How to satisfy Cybersecurity for FDA and EU?
Medical Device News April 2025 Regulatory Update
What are the TOP 3 FDA inspection issues?
Medical Device News March 2025 Regulatory Update
How to avoid Clinical Investigation for your Device?
FDA: Advantage of the Breakthrough Device Program
How and Who to build your Risk Management File?
The good, the bad and the ugly of certification bodies
Medical Device News January 2025 Regulatory Update
6 Tips to Grow as a QA RA Manager
TOP 5 common NCs on an ISO 13485 audit
How to perform your PMS for a Drug-Device Combination?
How to register a Medical Device in South Africa?
Medica: AI & MDR FLIP THE COIN
Easy Medical Device Great Summary 2024
What are the major pitfalls of Startups in Medical Devices?
Medical Device News December 2024 Regulatory Update