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