Blog
Expert guidance on FDA MAUDE monitoring, post-market surveillance automation, regulatory strategy, and AI-powered compliance for medical device teams.
No — MAUDE is still the live source for device adverse event data. AEMS launched in March 2026 with drug data only, and there is no public AEMS API. Here is what FDA's own pages say, verified against primary sources.
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 is consolidating its adverse event databases into AEMS. Here is what medical device companies need to know about the timeline, changes, and preparation steps.
Device data has not moved to AEMS yet, which makes this the cheap moment to prepare. SOP wording, the FDA pages to monitor, auditor documentation and PSUR data continuity — a practical checklist for RA and quality teams.
The openFDA device/event endpoint is alive and current: weekly refreshes, roughly 25 million records, no deprecation notice. A technical look at the endpoint today, what the AEMS cutover could change and why archiving raw responses protects your audit trail.
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