Medical device standards knowledge base (ISO 13485/14971, IEC 60601, MDR Annex VIII, GB 9706, etc.). Read-only MCP runtime for regulatory standards query across 27 knowledge hubs. Zero egress, zero cr
MCP server for regMD — Medical Device Regulatory Intelligence. Classify devices, query alerts, find pathways across 15 jurisdictions.
Medical device compliance tools. Self-assessment checklists for MDR / IVDR / SaMD / cybersecurity / post-market surveillance. Read-only, zero egress, audit-traceable.
A curated list of resources for medical device regulatory professionals — agencies, standards, databases, tools, and educational content.
AWS Agents for Humans (Professional track): Strands Agents SDK multi-profile agent for medtech regulatory monitoring, submission readiness, and clinic compliance.
SynomosAI / MedXpert 技能库 GitHub 镜像 · 31 个已发布 skill · 按六大使业务线组织 · 供 SkillsMP 自动发现
Medical device regulatory document translator. Read-only MCP tools for terminology lookup across NMPA/FDA/MDR/Japan PMDA — NOT a general translator. Audit-traceable, conservative translation stance.
MedXpert 医疗器械合规 AI 技能库 · 目录与安装指引
Medical device testing coordination. Read-only tool for querying accredited testing labs, test method standards (IEC/ISO/GB), sample requirements and testing timelines across NMPA/FDA/MDR.
Agent Skills in two lines: SynomosAI (general AI: local LLM, KB tooling, brand assets) & MedXpert (medical-device regulatory: NMPA/FDA/MDR/PMDA). Works with Claude, Codex, Cursor, Gemini CLI, Coze and 30+ clients.
MedXpert 医械注册实务知识库 · 公开同源源 (SSOT)
Medical device registration assistant (read-only MCP). Operates as a tool agent — does NOT provide medical advice or clinical judgment. For documentation query, regulatory path comparison, submission
MedXpert 全球医械法规连接器 (reg-connector) — read-only MCP server, NMPA/FDA/MDR/PMDA knowledge hubs (27 pivots), 4 tools, zero egress. Install-by-consent (AI may request, human approves).
Medical device registration operational toolkit. Read-only MCP tools for querying NMPA/FDA/MDR submission paths, fee schedules, document checklists, and procedural timelines. Audit-traceable.
FDA & EU MDR Medical Device UDI Decoder (GS1, HIBCC, ICCBBA) (python client)
Post-market surveillance agent for medical devices: EU MDR vigilance workflow and signal detection on real FDA MAUDE data, with Claude agents, deterministic rules and PRRC sign-off.
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.
Agent skills for EU medical device regulation that say where the rules stop. Statute-pinned, ablation-measured, source-verified.
FDA & EU MDR Medical Device UDI Decoder (GS1, HIBCC, ICCBBA) (typescript client)
Design control and risk management documents worked against ISO 13485, ISO 14971 and EU MDR — self-directed exercise on an independent device design
To associate your repository with the eu-mdr topic, visit your repo's landing page and select "manage topics."