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398 Episoder

1. #336: From Academia to FDA Clearance (True Quality Roadshow - Boston)

   Udgivet: 14.9.2023
2. #335: Accelerating SaMD Development in a Compliant Agile way

   Udgivet: 8.9.2023
3. #334: MedTech Funding and Preparing for Due Diligence

   Udgivet: 31.8.2023
4. #333: Exploring Breakthrough Device Designation

   Udgivet: 25.8.2023
5. #332: Regulatory Strategy and the Advantage of Diversity in MedTech

   Udgivet: 17.8.2023
6. #331: 28 Days To Save The World: Lessons Learned from a Pandemic Month of Supply Chain Issues

   Udgivet: 10.8.2023
7. #330: 3P510k: What Is a 510k 3rd Party Review, and What are the Benefits?

   Udgivet: 3.8.2023
8. #329 The Right Way to Start a QMS: When, How, & What

   Udgivet: 27.7.2023
9. #328 FDA Guidance on Artificial Intelligence (AI) in Medical Devices

   Udgivet: 20.7.2023
10. #327 Understanding the ROI of an eQMS

    Udgivet: 11.7.2023
11. #326 CSA vs. CSV: Modern Validation for Modern MedTech

    Udgivet: 7.7.2023
12. #325 The Role of dFMEAs in Risk Management for Medical Devices

    Udgivet: 30.6.2023
13. #325 The Role of dFMEAs in Risk Management for Medical Devices

    Udgivet: 29.6.2023
14. #324 Management Responsibility: The most important part of a QMS

    Udgivet: 23.6.2023
15. #323 The Combination Products Handbook

    Udgivet: 16.6.2023
16. Leaning into Lean Documentation

    Udgivet: 7.6.2023
17. Cybersecurity and the Future of MedTech

    Udgivet: 2.6.2023
18. How AI Can Help You Manage Risk

    Udgivet: 26.5.2023
19. Ad Promo and The Difference in Regulatory & Legal

    Udgivet: 24.5.2023
20. The Tools that Make Clinical Investigations

    Udgivet: 13.5.2023