Practical PMS guidance for FDA and Health Canada first — with selected global reference content where useful. Written from the RA/QA perspective.
Complete inspection preparation guide for medical device RA/QA professionals. Covers what FDA, EU NB, MDSAP, and Health Canada inspectors check for PMS compliance, the full inspection checklist, gap analysis methodology, PMS maturity model, top 10 audit findings, and how to conduct pre-inspection mock audits.
A side-by-side comparison of FDA and Health Canada post-market surveillance requirements for medical device manufacturers selling in both markets — covering reporting obligations, timelines, audit expectations, and harmonization under MDSAP.
A comprehensive reference for RA/QA professionals on FDA post-market surveillance requirements — covering MDR reporting (21 CFR 803), complaint handling, CAPA, trend analysis, and QMSR 2026 changes.
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.
External PMS means monitoring publicly available regulatory signals for events related to your device. Here is what the standards require and how to build an audit-ready evidence system.
By TrueMedDevice Team · Mar 25, 2026 · 5 min read | Today's FDA enforcement actions expose critical gaps in labeling adequacy, software validation, and supplier quality management that could trigger regulatory scrutiny across device categories.
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