Insights for Medical Device Professionals

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.