Practical PMS guidance for FDA and Health Canada first — with selected global reference content where useful. Written from the RA/QA perspective.
By TrueMedDevice Team · Apr 01, 2026 · 5 min read | Today's 10,384 signals reveal that software-related malfunctions and supply chain quality issues are the primary drivers of post-market risk, demanding immediate cross-functional action to build audit-ready evidence.
By TrueMedDevice Team · Mar 29, 2026 · 5 min read | Today's 26,202 signals reveal systemic quality control breakdowns in third-party servicing and persistent software-related malfunctions in connected devices.
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.
Everything RA/QA professionals need to know about Health Canada's post-market surveillance requirements — mandatory problem reporting under CMDR, recall procedures, MDALL licence obligations, and MDSAP audit expectations.
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