Latest / Let's Talk Risk! Podcast
Deep Dive: When the Risk Baseline and the QMS Both Break Down
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…
The skinny
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