Insights for Medical Device Professionals

This week’s FDA external signals reinforce a familiar RA/QA reality: your audit risk isn’t “missing a recall headline”—it’s failing to prove you reviewed it, assessed relevance, and recorded a decision. A high-quality external PMS system must produce: (1) a clear signal list, (2) relevance triage + rationale, (3) timestamps (Published/Captured/Reviewed), and (4) an exportable evidence pack.

This week saw 12 new FDA device recalls including 3 Class I events, plus Health Canada updated 47 medical device listings. Here is what your RA/QA team needs to know.