MCP server for regMD — Medical Device Regulatory Intelligence. Classify devices, query alerts, find pathways across 15 jurisdictions.
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Mar 26, 2026 - TypeScript
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eu-mdr
Here are 9 public repositories matching this topic...
A curated list of resources for medical device regulatory professionals — agencies, standards, databases, tools, and educational content.
awesome fda awesome-list medtech regulatory regulatory-affairs medical-devices regulatory-intelligence pmda 510k eu-mdr ce-marking medical-device-regulation
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Aug 6, 2026
Agent skills for EU medical device regulation that say where the rules stop. Statute-pinned, ablation-measured, source-verified.
regtech mdr medical-devices regulatory-compliance ivdr agent-skills claude-code claude-plugin eu-mdr medical-device-software
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Sep 10, 2026 - HTML
Healthcare-specific profile of the AI Incident Card. Maps severity/type fields onto FDA MedWatch (21 CFR §803), EU MDR vigilance (Articles 87 to 89), IMDRF AE Terminology, and a CTCAE-aligned 5-grade clinical severity scale. Healthcare-readiness scaffolding, not certification.
fda ai-safety healthtech ai-governance eu-mdr kinetic-gain-protocol-suite incident-disclosure imdrf medwatch adverse-event-reporting
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May 29, 2026
AI-powered Regulatory Intelligence for Medical Devices. RAG pipeline with semantic reranking across EU MDR, MPDG, MepV, UK MDR, and more.
python nlp chatbot openai cohere rag regulatory-affairs medical-devices streamlit vector-database regulatory-intelligence llm langchain chromadb semantic-reranking eu-mdr
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Feb 18, 2026 - Python
FDA & EU MDR Medical Device UDI Decoder (GS1, HIBCC, ICCBBA) (typescript client)
typescript sdk rapidapi gs1-128 medtech medical-device device-tracking healthtech hibcc isbt-128 eu-mdr fda-udi 21-cfr-801 iccbba
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Sep 1, 2026 - JavaScript
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.
adverse-events signal-detection pv static-html medical-device drug-safety pharmacovigilance healthtech pmda eu-mdr operator-surface kinetic-gain audit-stream medwatch
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Aug 22, 2026 - HTML
🌉 Maps HL7/FHIR healthcare records into AI-governance evidence — HIPAA + EU MDR + GDPR.
mcp healthcare fhir compliance hl7 hipaa claude ai-governance layer-0 csoai model-context-protocol mcp-server legacy-modernization eu-mdr meok-ai-labs a-100-100
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Jul 30, 2026 - Python
FDA & EU MDR Medical Device UDI Decoder (GS1, HIBCC, ICCBBA) (python client)
python sdk rapidapi gs1-128 medtech medical-device device-tracking healthtech hibcc isbt-128 eu-mdr fda-udi 21-cfr-801 iccbba
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Sep 1, 2026 - Python
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