A curated list of resources for medical device regulatory professionals — agencies, standards, databases, tools, and educational content.

AI-powered Regulatory Intelligence for Medical Devices. RAG pipeline with semantic reranking across EU MDR, MPDG, MepV, UK MDR, and more.

MCP server for regMD — Medical Device Regulatory Intelligence. Classify devices, query alerts, find pathways across 15 jurisdictions.

Healthcare-specific profile of the AI Incident Card. Maps severity/type fields onto FDA MedWatch (21 CFR §803), EU MDR vigilance (Articles 87–89), IMDRF AE Terminology, and a CTCAE-aligned 5-grade clinical severity scale. Healthcare-readiness scaffolding, not certification.