11 articles
Search the FDA MAUDE database for medical device adverse event reports. How to query MAUDE, understand MDR reporting under 21 CFR 803, use the openFDA API, and set up real-time monitoring.
How to register medical devices in Japan with PMDA. 4-class system, Shonin vs 510(k), Ninsho certification, DMAL requirements, MHLW Ordinance 169 — complete comparison guide.
FDA launched AEMS in March 2026 to replace MAUDE, FAERS & 5 other databases. What changes for medical device teams — new features, timeline, API migration & what stays the same.
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.
Everything manufacturers need to know about EUDAMED — 6 modules, registration deadlines, SRN requirements, UDI-DI submission & rollout status. Includes step-by-step registration walkthrough.
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 top medical device companies use real-time regulatory intelligence to catch FDA, EMA & NMPA changes 10x faster. Practical framework for RA teams with tool comparison.
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.