Practical PMS guidance for FDA and Health Canada first — with selected global reference content where useful. Written from the RA/QA perspective.
Pulse oximeters are among the most widely used medical monitoring devices, yet they are associated with multiple regulatory events. This article analyzes the regulatory landscape including 510(k) clearances, recall trends, MAUDE data, and what RAQA teams should monitor.
By TrueMedDevice Team · Feb 25, 2026 · 5 min read | Today's 1,010 signals expose critical audit risks where high-volume adverse events for active implantables may indicate inadequate trending and cross-jurisdictional alignment in post-market surveillance systems.
By TrueMedDevice Team · Feb 24, 2026 · 5 min read | Today's data reveals a critical pattern: reprocessed single-use devices and software-driven systems are driving enforcement and adverse events, demanding immediate supplier oversight and design control updates.
By TrueMedDevice Team · Feb 20, 2026 · 5 min read | Today's 158 FDA enforcement actions expose critical gaps in supplier qualification, sterile barrier validation, and design verification that cascade into recalls and adverse events.
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.
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