12 articles
FDA Quality Management System Regulation (QMSR) took effect Feb 2, 2026. How Part 820 now incorporates ISO 13485:2016, CP 7382.850 replaces QSIT, and what RA/QA teams must do.
Free guide to searching FDA MAUDE & AEMS adverse event database. Learn 21 CFR 803 MDR rules, openFDA API Python queries, and real-time recall alerts.
Compare Japan PMDA vs US FDA medical device classification (Class I-IV), Shonin/Ninsho approvals, timeline, fees, and DMAL requirements. 2026 complete guide.
FDA launched AEMS in March 2026 to replace MAUDE. Compare AEMS vs MAUDE fields, openFDA API changes, and 2026 compliance deadlines. Read guide →
What do FDA recall Class I, II & III mean? Complete guide with real examples, manufacturer response requirements, reporting timelines & how to monitor recalls in real time.
EUDAMED first four modules became mandatory on 28 May 2026. Actor SRN, UDI/devices, certificates, market surveillance — plus legacy registration by 28 Nov 2026 and what still is not live.
Complete FDA 510(k) clearance guide — find predicate devices, choose Traditional vs Special vs Abbreviated pathways, 3-12 month review timelines, costs & top rejection reasons.
FDA 510(k)/PMA vs EU MDR CE marking side-by-side — classification, timelines, costs & post-market requirements. Decision framework for dual-market submissions.
Search and monitor FDA medical device recalls in real time — Class I/II/III lookup via openFDA API, automated alerts, MAUDE integration & free recall search tool.
Register medical devices with China's NMPA — CMDE review process, MAH requirements, in-country testing, Class I/II/III timelines & NMPA vs FDA 510(k) comparison. Guide for foreign manufacturers.
How MedTech RA teams automate post-market surveillance across 27 regulators. Download the 90-second regulatory signal monitoring framework.
The definitive list of 27 global medical device regulatory agencies — FDA, EMA, NMPA, PMDA, TGA & more. Organized by region with contact info, key requirements & official links.