Apr 17, 2026
Triaging Your QMS: Considerations Based on the New QMSR
59 minutes
Episodes
Ordered by publication date.
Mar 11, 2026
A Deep Dive into E&L and Biocomp Testing
22 minutes
Oct 27, 2025
Planning for FDA Shutdowns Now and in the Future
55 minutes
Sep 11, 2025
Should Wellness Products Come with a Warning?
1 hour 4 minutes
Jun 25, 2025
3 Most Common Premarket (Postmarket?) Review Issues FDA Sees
51 minutes
Jun 10, 2025
Why Are One-Third of MAUDE Reports a Problem?
56 minutes
May 30, 2025
FDA Guidance on Off-Label Communication, Part 2
55 minutes
May 30, 2025
FDA Guidance on Off-Label Communication, Part 1
50 minutes
Jan 23, 2025
Development Considerations for OTC Medtech, Part 2
59 minutes
Jan 23, 2025
Development Considerations for Over-the-Counter Medtech, Part 1
47 minutes
Jan 7, 2025
Device Descriptions in Regulatory Submissions
51 minutes
Nov 26, 2024
Regulatory Ramifications Due to the Presidential Election
53 minutes
Nov 20, 2024
Regulatory Considerations with an Assisted Suicide Machine
50 minutes
Sep 24, 2024
Predetermined Change Control Plans, Part 1
48 minutes
Sep 24, 2024
Predetermined Change Control Plans, Part 2
57 minutes
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