Practical PMS guidance for FDA and Health Canada first — with selected global reference content where useful. Written from the RA/QA perspective.
The most common mistake in medical device risk management: using FMEA Risk Priority Numbers for ISO 14971 risk evaluation. Here is why Detection is not a risk factor, what auditors look for, and what real FDA enforcement data shows.
PMCF (Post-Market Clinical Follow-up) explained at 4 levels — from playground analogy to the MDD-to-MDR evidence crisis. Covers MDCG 2020-7/2020-8 templates, PMCF plan writing, method selection, and why 'not applicable' rarely works with Notified Bodies.
Competitor recall monitoring explained at 4 levels — from playground analogy to strategic intelligence. Covers which databases to monitor, how to evaluate each signal, the regulatory requirement from EU MDR and FDA, and practical solutions for automated monitoring.
PSUR (Periodic Safety Update Report) explained at 4 levels — from a report card analogy to NB review strategy. Covers MDCG 2022-21 template, section-by-section guidance, common mistakes, and practical tips for RA/QA professionals writing their first PSUR.
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.
Comprehensive guide to post-market surveillance under EU MDR 2017/745 — covering PMS Plans, PSURs, PMCF, vigilance reporting (Articles 83-92), Notified Body audit expectations, and EUDAMED requirements for medical device manufacturers.
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.
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