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Expert guidance on FDA AEMS (formerly MAUDE) monitoring, post-market surveillance automation, regulatory strategy, and AI-powered compliance for medical device teams.
Yes. The FDA retired MAUDE as a standalone system in May 2026 and moved device adverse event data into AEMS, archive and all. Here is what changed, what stayed the same and how to keep your documentation honest.
Everything medical device professionals need to know about the FDA MAUDE database, from search strategies to overcoming its well-known limitations.
AI and NLP are reshaping how medical device companies detect safety signals, classify adverse events, and meet regulatory obligations under FDA and EU MDR requirements.
Why systematic monitoring of competitor adverse events gives medical device companies a strategic edge in regulatory planning, market positioning, and risk management.
Periodic Safety Update Reports are essential under EU MDR but notoriously time-consuming. Learn what can be automated and what still needs human judgment.
The FDA consolidated its adverse event databases into AEMS, completing the device migration in May 2026. Here is what changed for medical device companies and what the follow-on work looks like.
Device data moved to AEMS in May 2026. Here is the checklist to bring your SOPs, audit documentation and PSUR trend baselines in line with the completed transition.
The AEMS migration is complete, and the openFDA device/event endpoint is still the live delivery API — weekly refreshes, roughly 25 million records, no deprecation. A technical look at the endpoint now, what the cutover is changing under the hood and why archiving raw responses protects your audit trail.
Stop manually searching FDA databases. Get AI-powered adverse event monitoring and compliance-ready reports delivered weekly.
