Practical PMS guidance for FDA and Health Canada first — with selected global reference content where useful. Written from the RA/QA perspective.
Canadian distributors and importers often want more than a supplier brochure in the product file. Here's what MDALL, MDEL, recalls, and safety alerts each tell you, what to capture in the file, and what supplier follow-up questions naturally fall out of the check.
Importers, distributors, procurement, supplier-quality, and RA/QA teams often want a dated public-source record before placing a PO or reordering a medical device SKU. Here's what FDA and Health Canada publish, what a useful pre-PO snapshot looks like, and what the check is not.
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.
Adverse event reporting explained at 4 levels — from simple analogy to multi-jurisdiction filing strategy. Includes the exact reporting timelines for FDA, EU MDR, Health Canada, Japan, Australia, and China, plus the reportability decision tree every RA/QA professional needs.
Post-market surveillance explained at 4 levels — from a 5-year-old's analogy to top researcher analysis. Covers why PMS exists, what RA/QA professionals must do daily, the regulations across FDA/EU/HC, and where the field is heading with RWE and AI signal detection.
How to build a single post-market surveillance system that satisfies FDA, EU MDR, Health Canada, Japan, and other jurisdictions simultaneously. Covers the 8-component architecture, ISO 13485 foundation, MDSAP harmonization, implementation roadmap, ROI analysis, and how automated external monitoring platforms transform RA/QA day-to-day work.
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.
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.
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