Deep Dive: When the Risk Baseline and the QMS Both Break Down

Podcast: Let's Talk Risk! Podcast · Where MedTech professionals gain clarity and confidence to navigate complex decisions.

Opublikowano: 2026-09-25

The baseline is completely broken and the iteration process is blind. FDA’s August 21, 2026 warning letter to Pensar Medical LLC illustrates a failure that goes well beyond incomplete documentation. The underlying risk-management foundation was weak. Risk-control verification remained incomplete for critical areas, and FDA reportedly found no design, process, or use-related FMEAs for the WoundPro product line. At the same time, key QMS processes were also failing. Key highlights covered in the audio: * Risk analysis was incomplete or missing. Critical risk controls remained unverified, and some products la...