MCP server for regMD — Medical Device Regulatory Intelligence. Classify devices, query alerts, find pathways across 15 jurisdictions.
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Updated
Mar 26, 2026 - TypeScript
MCP server for regMD — Medical Device Regulatory Intelligence. Classify devices, query alerts, find pathways across 15 jurisdictions.
AI-powered Regulatory Intelligence for Medical Devices. RAG pipeline with semantic reranking across EU MDR, MPDG, MepV, UK MDR, and more.
Operator surface for adverse-event queue, signal-detection clusters, regulator-reporting deadlines (FDA MedWatch 15-day / EU MDR vigilance / PMDA), and causality-assessment workflow. Browser-only, no telemetry. AGPL-3.0.
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.
A curated list of resources for medical device regulatory professionals — agencies, standards, databases, tools, and educational content.
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