A list of awesome medtech requirements tools, libraries, software and resources.
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Sep 23, 2026 - Python
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iso13485
Here are 14 public repositories matching this topic...
CERN's quality assurance plan (QAP) to solve the document naming convention problem.
go golang engineering mechanical-engineering quality-assurance cern qap cae qms plm iso-13485 iso9001 iso-9001 product-lifecycle-management design-history quality-assurance-plan iso13485 document-naming quality-management-system
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Sep 12, 2022 - Go
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
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Oct 11, 2026 - Python
MedXpert 医疗器械合规 AI 技能库 · 目录与安装指引
fda healthcare zero-dependency samd medical-device lgd regulatory-affairs local-first iso13485 ai-governance nmpa agent-skills claude-code skill-library eu-mdr clinical-evaluation workbuddy iso14971 medxpert medical-device-compliance
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Oct 11, 2026
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 healthcare knowledge-base medical-device rag lgd regulatory-affairs iso13485 nmpa eu-mdr medxpert
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Oct 6, 2026
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).
mcp fda healthcare knowledge-base rag lgd regulatory-affairs medical-devices iso13485 pmda nmpa model-context-protocol mcp-server eu-mdr clinical-evaluation medxpert
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Oct 6, 2026 - Python
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.
fda healthcare wechat knowledge-base content-marketing wechat-official-account medical-device rag regulatory-affairs local-first iso13485 llm nmpa eu-mdr clinical-evaluation medxpert
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Sep 27, 2026 - Python
MedXpert 医械注册实务知识库 · 公开同源源 (SSOT)
translation fda healthcare knowledge-base medical-device quality-management regulatory rag regulatory-affairs iso13485 pmda nmpa eu-mdr clinical-evaluation ce-marking iso14971 medxpert
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Sep 27, 2026
ComplianceAI dashboard that streams AI reviews of medical-device documentation across ISO 13485, IEC 62304, and EU MDR
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Sep 9, 2026 - TypeScript
Top Quality Management System (QMS) 🌟 Star if you like it! 🌟
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Aug 27, 2026
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