All Episodes
Medical Device made Easy Podcast — 312 episodes
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
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?
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
PCCP – The Magic tool for SaMD in the US?
IEC 60601-1-8 How to test your Medical Device alarms?
How to build the perfect Quality Management System?
Is FMEA bad for your Risk Management?
How MDR and IVDR code can save you money?
Medical Device News November 2024 Regulatory Update
What does a strategy for regulatory compliance looks like?
What are the TOP 3 issues on CAPAs?
Medical Device News, October 2024 Regulatory Update
How to select the best plastic for your Medical Device?
UK vs EU vs US – How to switch to another region easily?
How to do a PMCF Literature Search for Medical Devices?
Medical Device News, Septembre 2024 Regulatory Update
How to use AI GPT for your Quality and Regulatory work?
How to go from Zero to Hero in Medical Devices?
Manage the Transfer/Renewal/Surveillance/Change of your CE certificate
How to use Harmonized Standards for Medical Devices?
IVDR Class D – Lesson learned from Notified Bodies
EU MDR Major update: Interruption or Discontinuation of supply!
How to register your Medical Device in the UAE?
EU Battery Regulation – How to be ready?
AI Act – What are the challenges for Medical Devices?
Medical Device News, July 2024 Regulatory Update
How to submit your AI/ML SAMD the right way?
AFNOR – How is a Notified Body designated?
Cleaning Validation – How to select the worst case?
Medical Device News June 2024 Regulatory Update
Summative Evaluation – Common mistakes
Are you more Corrections or Corrective Actions or Preventive Actions?
How to select and evaluate your Contract Manufacturer?
Quality Field Service for Medical Devices
Medical Device NewsMAY 2024 Regulatory Update
Why and how to build a Quality Culture?
What is the impact of AI Act on Medical Devices?
Radiation Sterilisation Master File (ISO 11137 & 11607)
Medical Device News April 2024 Regulatory Update
How to benefit from Surveys to build Clinical Evidence?
How to do Postmarketing Surveillance the right way?
Learn more about FDA QMSR alignment with ISO 13485
Medical Device News March 2024 Regulatory Update
New EU Proposal – EUDAMED, IVDR & Shortage
Will EtO gaz become a Medical Device?
How to get your interview prepared?
Medical Device News february 2024 Regulatory Update
Why you should use Pre-Submission or Q-Sub with FDA?
You are not the Physical Manufacturer, can you be MDR certified?
MEDICA 2023 – InterviewS with Startups, Service Providers, Notified Bodies…
WARNING! APPLY TO YOUR NOTIFIED BODY NOW!
Medical Device News – january 2024 Regulatory Update
Regulatory Maturity Model – Heatmap (MEDICA 2023)
Life of QA RA Podcasters?
Why should you invest in your Regulatory Team?
What is Usability for Medical Devices?
Medical Device News: December 2023 Regulatory Update
What is the situation regarding digitalization in Medtech?
How to find your Predicate Device for your 510K Submission?
How to CE certify a Calculator, Risk Score…?
Medical Device News – November 2023 Regulatory Update
Validate your Iphone, Samsung Galaxy, Huawei… for your Software
Afrisummit 2023 Interviews Part 2 – Egypt Situation
Afrisummit 2023 Interviews Part 1
What are some pitfalls to avoid during Software Design?
October 2023 Regulatory Update
What is the EUDAMED Updates?
Interviews on Being The PRRC (Part 2)
MEDICAL DEVICE NEWS – SEPTEMBER 2023 Regulatory Update
How to perform your Cleaning Validation in practice?
What are the Acceptance Criteria for your Clinical Evaluation?
Why you should automate your Software validation?
Hire your QA RA person with no Budget
Who should be on your Risk Management Dream Team?
Artificial Intelligence in the Medical Device Industry
Validation of Quality Software in Medical Devices
How to register Medical Devices in Saudi Arabia?
Medical Device News – July 2023 Regulatory Update
What should you know on UKCA extension
How to connect Software dev and QA RA Team
The great misunderstanding of EU MDR amendments
Medical Device News -June 2023 regulatory update
How to master Regulatory Intelligence?
What if your Medical Device Company goes Bankrupt?
Technical Files Inconsistencies Identified by Notified Bodies
The truth about the UK vs EU situation
Medical Device news – May 2023 Regulatory Update
Transition to Agile for Software as Medical Device
Prepare your audit like a PRO
What is a SOUP for your Software Development?
Medical Device News – March 2023 Regulatory Update
How to perform Risk Management for a Software ?
How to create a Proactive Postmarketing Surveillance? [EU MDR]
What you should know about Vigilance Reporting for Medical Devices?
Medical Device News: March 2023 Regulatory Update
Medical Device News – October 2022 Regulatory Update
How to Certify a Software as Medical Device? (Dr. Abtin Rad – TÜV SÜD)
Better to be a Consultant or a Full-time employee? [Lifescience industry]
What can we learn from the first MDR audits? [Martin Witte -TÜV SÜD]
How to implement Vigilance Reporting for MDR and IVDR?
System and Procedure Pack the RETURN with Erik Vollebregt
How to interpret the first Expert Panel Opinion? [Bassil Akra]
Medical Device News: The July 2021 Update [MDR IVDR FDA SFDA]
How to build your State-of-the-art for your Medical Devices?
How Intellectual Property is linked to the Medical Device Regulation?
How to perform a good Clinical Investigation with Helene Quie
How to perform a Biological Evaluation for your Medical Device?
Medical Device News – June 2021 Update [EU MDR Date of Application]
EU MDR Survey: What is the Industry’s opinion? [Catherine Higginson]
MDR is coming so brace yourself with Erik Vollebregt
FDA: Is the Emergency Use Authorization worth it? (EUA)
Medical Device News – May 2021 Update [EU MDR 2017/745]
Checklist – What is important before the EU MDR Date of Application?
How to perform correctly a Merger & Acquisition during the MDR transition?
Will it be really difficult for IVD manufacturers? [IVDR 2017/746]
How to create a Label under MDR? (Questions & Answers)
How System and Procedure Pack are regulated under EU MDR?
How to import your Medical Devices with an Independent Importer?
What is the Medical Device News? [March 2021 update]
The best design methods for successful development? [Jon Speer]
How to perform your PMS more easily with Ivan Perez Chamorro?
Medical Device News – January 2021 Update (Monir El Azzouzi)
How to deal with Significant Changes within MDR & IVDR with Martin Witte
How to register a Medical Device in Mexico? [Josué Garza]
How a Quality & Regulatory training can help you? [Sofmedica]
What are Common Specifications under EU MDR & IVDR?
How to certify a self-testing device under IVDR? [Erik Vollebregt]
What is the cost of EU MDR 2017/745? [Catherine Higginson]
How to register your Medical Device in the ASEAN region?
The latest news on Brexit, Swixit and EU MDR [Medical Device News]
How to register ATMP-Device combination products?
How to get some help from Medical Device Regulators with Cliff Bleustein
How can GDPR impact Medical Devices with Erik Vollebregt
Be successful at your MDR and IVDR audit with Martin Witte
Medical Device News – August 2020 Review (Monir El Azzouzi)
How to switch quickly to a Virtual Conference with TOPRA
Best practice for Device Testing with Michael Wetherington
Best overview of IEC 60601 for Medical Device electrical equipment
Medical Device News – July 2020 Update on Quality and Regulatory for Medical Devices
Learn UDI code for Medical Devices with Sylvia Reingardt
Understand IEC 62304 for Medical Device Software with Adnan Ashfaq
How to become a PRRC with TEAM-PRRC (EU MDR & IVDR)
Medical Device News – June 2020 Update
The secrets to being EU MDR certified with Shokoufeh Khodabandeh
How to perform your Process Validation with Adnan Ashfaq (IQ OQ PQ)
How to execute your Internal Audits? (Medical Device companies)
Medical Device News – May 2020 Review with Monir El Azzouzi
What means Sufficient Clinical Data with Bassil Akra (EU MDR)
What is the Notified Body situation? (Bassil Akra from TUV SUD)
How to get ISO 13485 certified? (Quality Management System)
How to get your Digital Health Application reimbursed in Germany? (DIGA)
Medical Device News – April 2020 Regulatory Update
How to calculate your sample size with Jon Bergsteinsson
The 1-year delay for the EU MDR 2017/745 with Erik Vollebregt
Medical Device School – Why are Staff hiding problems to QA & RA?
MDR & Drug-Device Combination Products with Theresa Jeary
Medical Device News – March 2020 Review (EU MDR)
What is a Significant Change for your Medical Device? with Erik Vollebregt
All about Class Is, Im and Ir with Elem Ayne (EU MDR 2017/745)
Cybersecurity for your Medical Devices with Erik Vollebregt
Medical Device Regulatory Update – February 2020
Do your Economic Operators need a Quality Management System?
Create your intended purpose with Cesare Magri (Medical Device)
Medical Device School: What should verify your Economic Operators?
Clinical Data for Low Risk Medical Devices with Robert van Boxtel
Medical Device School – Who controls your Economic Operators?
Are Brexit, Swixit, and Turkxit a reality? with Erik Vollebregt
Medical Device School – Who are your Economic Operators?
Swixit or not Swixit? this is the question with Ronald Boumans
Medical Device School – Process Validation or Verification?
Episode 61 – Medical Device Regulatory Update: January 2020
How to register your Device in Brazil with Tania Aprigliano? (ANVISA)
Why is it Awesome to work in a Quality or Regulatory affairs job?
How to create a QMS compliant to MDR with Stefan Bolleininger
How to register your Medical Device through 510k with Michelle Lott
Medical Device School: How to audit your Suppliers?
Post-Marketing Clinical Follow-up with Helene Quie (PMCF)
I wish you a Happy New Year 2020 with Monir El Azzouzi
6 ways to collect Clinical Data with David Rutledge
Class I Medical Devices under MDR with Erik Vollebregt (PART 2)
Corrigendum 2 – Changes for Class I Devices with Erik Vollebregt (Part 1)
How to evaluate your Medical Devices in 3 Steps with Heikki Pitkänen?
Responsibility of a Distributor in MDR & IVDR with Nicolaj Nitzsch
Medical Device School: Product Development or Documentation creation?
EUDAMED is delayed, so What? with Richard Houlihan
Literature Search for your CER with Ed Drower
Medical Device School: How to build a Gap Assessment Tool?
How to validate an eQMS with Jacob Sjorslev
How to implement an eQMS with Jacob Sjorslev
Medical Device School – Most important issues on your CAPA (ISO 13485)
Medical Device Disruptions at Hospitals with Stefan Krojer
5 FDA Myths for Start-Ups with Justin Bushko
GDPR & MDR for Medical Applications with Jovan Stevovic
Register your Medical Device in the US with Michelle Lott (FDA)
New rules for the In-Vitro Diagnostic Industry with Maurizio Suppo
Learn Post Market Surveillance with Natasha Bankowski
Product Equivalence for Clinical Evaluation Report (CER) with Helene Quie
Episode 39 – Networking at Medical Device events with Lynda Wight
Episode 38 – Be the Best Candidate Ever with Mitch Robbins
Episode 37 – Usability & Human Factor with Sharon Ayd
Episode 36 – How to choose your PRRC with Erik Vollebregt
Episode 35 – Digitalization of QA RA with Michael Kania
Episode 34 – Real-World Data for Medical Devices with Alethea Wieland
Episode 33 – Notified Bodies Lay Down Service with Erik Vollebregt
Episode 32 – Pakistan Registration Process with Muhammad Sohail
Episode 31 – First Regulatory Affairs Job with Karandeep Badwal
Episode 30 – Promotional Compliance with Darshan Kulkarni
Episode 29 – 5 Steps to create a QMS with Jason Lim
Episode 28 – OBL & OEM with Stefan Bolleininger – Part 2
Episode 27 – OEM & OBL Model with Stefan Bolleininger [Part 1]
Episode 26 – IVDR preparation with Andreas Stange
Episode 25 – EUDAMED secrets with Richard Houlihan
Episode 24 – Myths about consultants with Thomas McMann
Episode 23- TOP 10 criteria to select a CRO with Alethea Wieland
Episode 22 – Clinical Trial with Alethea Wieland
Episode 21 – How to master Regulatory Affairs with Samantha Alsbury
Episode 20 – What is a Blockchain with Khuram Malik
Episode 19 – Rule 11 for Software Devices with Cyrille Michaud
Episode 18 – QA RA Recruitment situation with Petra Ognjenovic
Episode 17 – Unannounced audit stories with Florent Guyon
Episode 16 – From Disease to a Medical Device with Sean Hamilton
Episode 15 – MDR & IVDR discussion with Erik Vollebregt Part 2
Episode 14 – MDR & IVDR stories with Erik Vollebregt (Part 1)
Episode 13 – Brexit Talk with Richard Young
Episode 12 – How to create an ISO Standard with Marcelo Antunes
Episode 11 – Medical Device Software Validation
Episode 10 – Understand MDSAP with Angelina Hakim
Episode 9 – Entrepreneurial journey with Ivan Perez Chamorro
Episode 8 – From Correction to Prevention with ODIAC
Episode 7 – Make your KPIs Green again
Episode 6 – What are the 6 types of Medical Device Audits
Episode 5 – Medtech Prediction 2019
Episode 4 – UDI for Unique Device Identification
Episode 3 – Is my Product a Medical Device in Europe?
Episode 2 – New EU Medical Device Regulation MDR 2017/745
Episode 1 – Introduction to the Medical Device made Easy Podcast