A list of awesome medtech requirements tools, libraries, software and resources.
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Sep 23, 2026 - Python
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iso14971
Here are 6 public repositories matching this topic...
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
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
Python toolkit for generating FDA/IEC-compliant SaMD validation packages — IQ/OQ/PQ protocols, ISO 14971 risk management, IEC 62304 lifecycle, SBOM, and cybersecurity checklists.
python validation fda cybersecurity samd medical-device regulatory-affairs iec62304 iso14971 iq-oq-pq
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Sep 23, 2026 - Python
Premarket cybersecurity documentation package for a connected medical device, structured to FD&C Act section 524B: threat model, ISO 14971 security risk assessment, CycloneDX SBOM, post-market plan
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Sep 13, 2026
按 ISO 14971:2019（+ ISO/TR 24971 应用指南）生成风险管理文件骨架：危害登记表、5×5 概率×严重度风险矩阵、可接受性准则、风险控制措施跟踪、剩余风险与受益-风险分析。把「风险管理贯穿生命周期」落成一条命令。
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Oct 14, 2026 - Python
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