Practical PMS guidance for FDA and Health Canada first — with selected global reference content where useful. Written from the RA/QA perspective.
Engineering finds a field problem. Is it a correction, removal, or recall? Learn the 21 CFR 806 decision tree, health hazard evaluation process, and what happens when you miss the 10-day reporting window.
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.
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.
The exact questions FDA inspectors, EU Notified Body auditors, and MDSAP auditors ask about your PMS system — explained at 4 levels. Includes the 8 documents to have ready, the 'thread-pull' technique inspectors use, and how pre-inspection intelligence targets your weak spots.
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.
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