Insights for Medical Device Professionals

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.

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.

A comprehensive reference for RA/QA professionals on FDA post-market surveillance requirements — covering MDR reporting (21 CFR 803), complaint handling, CAPA, trend analysis, and QMSR 2026 changes.

This week’s FDA external signals reinforce a familiar RA/QA reality: your audit risk isn’t “missing a recall headline”—it’s failing to prove you reviewed it, assessed relevance, and recorded a decision. A high-quality external PMS system must produce: (1) a clear signal list, (2) relevance triage + rationale, (3) timestamps (Published/Captured/Reviewed), and (4) an exportable evidence pack.

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.

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.