Practical PMS guidance for FDA and Health Canada first — with selected global reference content where useful. Written from the RA/QA perspective.
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.
Complete inspection preparation guide for medical device RA/QA professionals. Covers what FDA, EU NB, MDSAP, and Health Canada inspectors check for PMS compliance, the full inspection checklist, gap analysis methodology, PMS maturity model, top 10 audit findings, and how to conduct pre-inspection mock audits.
Practical guide explaining the two streams of PMS — internal data (complaints, CAPA, production, service) and external data (regulatory databases, literature, competitor events). Covers daily/weekly/monthly workflows for RA/QA professionals, how to connect both streams, and what regulators inspect.
Comprehensive guide to medical device PMS requirements across 7 jurisdictions — Japan (PMDA), Australia (TGA), China (NMPA), Brazil (ANVISA), UK (MHRA), South Korea (MFDS), and India (CDSCO). Includes reporting timelines, local representative requirements, and MDSAP harmonization.
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.
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