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| Episode | Transcript | 🇩🇪 German | 🇬🇧 English |
|---|---|---|---|
| 2026-04 |
Notified bodies are upgrading, part 2
Podcast • 35 Minutes
|
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| 2026-03 |
Notified bodies are upgrading
Podcast • 20 Minutes
|
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| 2026-03 |
KI-Praxis bei Olympus
Podcast • 46 Minuten
|
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| 2026-02 |
Fourth Edition of IEC 60601-1
Podcast • 21 Minutes
|
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| 2026-01 |
EUDAMED Transition Periods
Podcast • 22 Minutes
|
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| Episode | Transcript | 🇩🇪 German | 🇬🇧 English |
|---|---|---|---|
| 2025-14 |
How ROCHE is tackling EU digital regulation
Podcast • 33 minutes
|
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| 2025-13 |
The great LLM Dream of RA
Podcast • 22 minutes
|
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| 2025-12 |
Recommendations from a Certification Body
Podcast • 28 minutes
|
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| 2025-11 |
Minimizing (medical) Product Liability Risks
Podcast • 16 minutes
|
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| 2025-10 |
The Corporate Will of Medical Device Manufacturers
Podcast • 38 minutes
|
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| 2025-09 |
TÜV Rheinland & the Structured Dialogue
Podcast • 38 minutes
|
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| 2025-08 |
MDR Certifications at BSI
Podcast • 19 minutes
|
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| 2025-07 |
AI Act – A Practical Report
Podcast • 28 minutes
|
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| 2025-06 |
News from Denmark
Podcast • 21 minutes
|
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| 2025-05 |
Impact of the Ecodesign Directive on medical devices and IVDs
Podcast • 21 minutes
|
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| 2025-04 |
Accessibility
Podcast • 12 minutes
|
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| 2025-03 |
Target Agreements
Podcast • 9 minutes
|
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| 2025-02 |
Notified Body or Certification Body?
Podcast • 17 minutes
|
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| 2025-01 |
How I almost got fired
Podcast • 6 minutes
|
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| Episode | Transcript | 🇩🇪 German | 🇬🇧 English |
|---|---|---|---|
| 2024-16 |
A Life Dedicated to Regulatory Affairs
Podcast • 16 minutes
|
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| 2024-15 |
Insights from working with over 100 companies
Podcast • 28 minutes
|
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| 2024-14 |
Living Forever: Security in Uncertain Times
Podcast • 25 minutes
|
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| 2024-13 |
What does it mean to be a Regulatory Affairs Manager?
Podcast • 20 minutes
|
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| 2024-12 |
What seems simple but isn't: What are hazards according to ISO 14971?
Podcast • 20 minutes
|
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| 2024-11 |
Driving your own company to ruin
Podcast • 12 minutes
|
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| 2024-10 |
The Successful Regulatory Affairs Executive
Podcast • 20 minutes
|
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| 2024-09 |
Best Practices in software development
Podcast • 17 minutes
|
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| 2024-08 |
Fast international approval thanks to usability
Podcast • 20 minutes
|
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| 2024-07 |
How you can directly help the healthcare system
Podcast • 14 minutes
|
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| 2024-06 |
Legal requirements for cloud solutions, with Prof. Strittmatter
Podcast • 31 minutes
|
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| 2024-05 |
What the EU AI Act means for medical device manufacturers
Podcast • 25 minutes
|
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| 2024-04 |
Generate revenue quickly in the large U.S. market with medical devices
Podcast • 16 minutes
|
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| 2024-03 |
Product liability: what manufacturers can expect
Podcast • 23 minutes
|
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| 2024-02 |
Don't be afraid of FDA inspections
Podcast • 20 minutes
|
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| 2024-01 |
Is the Data Act relevant for medical device manufacturers? A conversation with Prof. Dr. Marc Strittmatter
Podcast • 35 minutes
|
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| Episode | Transcript | 🇩🇪 German | 🇬🇧 English |
|---|---|---|---|
| 2023-19 |
Get to market faster with phantoms!
Podcast • 16 minutes
|
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| 2023-18 |
Faster time to market with digital production
Podcast • 19 minutes
|
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| 2023-17 |
Digital Transformation with Polarion
Podcast • 16 minutes
|
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| 2023-16 |
Digital Twins in Medical Technology
Podcast • 30 minutes
|
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| 2023-15 |
Software platforms for the healthcare industry
Podcast • 26 minutes
|
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| 2023-14 |
Placing on the market: a concept that needs to be understood
Podcast • 22 minutes
|
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| 2023-13 |
A Career as a Regulatory Affairs Manager
Podcast • 22 minutes
|
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| 2023-12 |
Unjustified regulatory requirements?
Podcast • 17 minutes
|
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| 2023-11 |
PFAS Regulation: New Challenges for Manufacturers
Podcast • 29 minutes
|
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| 2023-10 |
Regulatory Intelligence
Podcast • 21 minutes
|
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| 2023-09 |
What is ASCA, and who does it help?
Podcast • 16 minutes
|
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| 2023-08 |
Banking regulation
Podcast • 32 minutes
|
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| 2023-07 |
Functional Safety
Podcast • 16 minutes
|
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| 2023-06 |
Risk Management Tools
Podcast • 19 minutes
|
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| 2023-05 |
Last resort: special permits
Podcast • 12 minutes
|
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| 2023-04 |
IT Security: Expectations of Notified Bodies
Podcast • 14 minutes
|
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| 2023-03 |
Amendment to the MDR Transitional Provisions
Podcast • 27 minutes
|
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| 2023-02 |
Why Animal Testing Is Almost Always Unnecessary
Podcast • 14 minutes
|
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| 2023-01 |
Hospital beds for Ghana
Podcast • 18 minutes
|
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| Episode | Transcript | 🇩🇪 German | 🇬🇧 English |
|---|---|---|---|
| 2022-14 |
The three hurdles that IVD manufacturers face
Podcast • 16 minutes
|
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| 2022-13 |
Appendix XVI products
Podcast • 16 minutes
|
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| 2022-12 |
Sale of Medical Devices in Turkey
Podcast • 11 minutes
|
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| 2022-11 |
Cybercrime Law
Podcast • 19 minutes
|
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| 2022-10 |
The Interplay Between Risk Management and IT Security
Podcast • 16 minutes
|
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| 2022-09 |
In Vitro Diagnostics in Pathology
Podcast • 17 minutes
|
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| 2022-08 |
Regulatory Strategy
Podcast • 19 minutes
|
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| 2022-07 |
Medical Software Development
Podcast • 21 minutes
|
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| 2022-06 |
Usability in Medical Devices
Podcast • 20 minutes
|
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| 2022-05 |
The Three Dimensions of Traceability
Podcast • 16 minutes
|
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| 2022-04 |
Building Development Teams: Why Startups Often Fail
Podcast • 28 minutes
|
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| 2022-03 |
Sustainability
Podcast • 17 minutes
|
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| 2022-02 |
Production validation
Podcast • 19 minutes
|
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| 2022-01 |
Telematics Infrastructure - Breaking the Cycle?
Podcast • 21 minutes
|
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| Episode | Transcript | 🇩🇪 German | 🇬🇧 English |
|---|---|---|---|
| 2021-26 |
Digital Transformation
Podcast • 19 minutes
|
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| 2021-25 |
Interoperability
Podcast • 20 minutes
|
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| 2021-24 |
Regulatory Affairs Manager in Small Businesses
Podcast • 13 minutes
|
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| 2021-23 |
Code Generation for Medical Devices
Podcast • 21 minutes
|
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| 2021-21 |
Financing for Medical Device Manufacturers
Podcast • 18 minutes
|
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| 2021-20 |
The Hurdles Faced by a Startup
Podcast • 29 minutes
|
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| 2021-19 |
From the world of electrical products: Whitness testing and descriptive reports
Podcast • 17 minutes
|
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| 2021-18 |
Class I standalone software?
Podcast • 17 minutes
|
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| 2021-17 |
7 days left until the MDR – what’s changing at the national level
Podcast • 9 minutes
|
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| 2021-16 |
Usability evaluations of COVID-19 rapid tests
Podcast • 12 minutes
|
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| 2021-15 |
Resolving trade disputes involving medical devices
Podcast • 18 minutes
|
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| 2021-14 |
Textile medical devices
Podcast • 13 minutes
|
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| 2021-13 |
Requirements for EU Authorized Representatives
Podcast • 13 minutes
|
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| 2021-12 |
New family of standards for autonomous cognitive AI systems
Podcast • 29 minutes
|
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| 2021-11 |
Barcode verifiers: a must-have for all medical device manufacturers?
Podcast • 17 minutes
|
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| 2021-10 |
Why some startups succeed and others don't
Podcast • 39 minutes
|
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| 2021-09 |
IEC 60601-1-2 AMD1:2020 - Catching Up with Reality
Podcast • 29 minutes
|
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| 2021-08 |
Marketing Medical Devices in the UK Despite Brexit
Podcast • 27 minutes
|
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| 2021-07 |
Sample size planning for clinical trials of medical devices and IVDs
Podcast • 27 minutes
|
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| 2021-06 |
Can medical devices be reimbursed as assistive devices? Is that possible?
Podcast • 24 minutes
|
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| 2021-05 |
Regulatory Science - Why We Need It
Podcast • 32 minutes
|
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| 2021-04 |
Product Liability for Medical Devices
Podcast • 14 minutes
|
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| 2021-03 |
Competitive advantages through IT security
Podcast • 21 minutes
|
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| 2021-02 |
Transfer Learning: Avoiding Regulatory Pitfalls for Medical Devices
Podcast • 31 minutes
|
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| 2021-01 |
Recycling and Disposal of Medical Devices
Podcast • 19 minutes
|
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| Episode | Transcript | 🇩🇪 German | 🇬🇧 English |
|---|---|---|---|
| 2020-15 |
DIGA - Firsthand experience
Podcast • 27 minutes
|
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| 2020-14 |
New IVDR Requirements for Laboratory-Developed Tests (LDTs)
Podcast • 23 minutes
|
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| 2020-13 |
Webinar on the FDA
Podcast • 5 minutes
|
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| 2020-12 |
Interpretability of Machine Learning Models
Podcast • 20 minutes
|
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| 2020-11 |
Traceability - Meeting Regulatory Requirements
Podcast • 19 minutes
|
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| 2020-10 |
Medical devices as autonomous systems
Podcast • 24 minutes
|
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| 2020-09 |
Computer-Based Modeling and Simulation for Medical Devices
Podcast • 23 minutes
|
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| 2020-08 |
ISO 27001 (not only) for medical device manufacturers
Podcast • 18 minutes
|
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| 2020-07 |
Clinical evaluations
Podcast • 10 minutes
|
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| 2020-06 |
Online and hybrid seminars
Podcast • 11 minutes
|
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| 2020-05 |
Validation of ML Libraries
Podcast • 26 minutes
|
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| 2020-04 |
International Approval
Podcast • 22 minutes
|
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| 2020-03 |
QSVs and the War of the Roses
Podcast • 14 minutes
|
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| 2020-02 |
The State of the Art
Podcast • 17 minutes
|
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| 2020-01 |
The Medical Device File
Podcast • 14 minutes
|
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