IoMT Compliance（智能医疗器械IoMT合规）
Compliance guide for connected medical devices that combine sensors, a companion app and a cloud service: it lays out the SaMD and SiMD registration paths, cybersecurity expectations, UDI traceability and remote patient monitoring scope across NMPA, FDA and EU MDR. Produces a submission-document che
as observed 2026-11-06T15:44:01.797Z- Identifier
medical-device-iomt-compliance- Source
- ClawHub
- Version observed
- 1.0.3
- Source repository
- not published
- Repository observation
- No source repository listed
- First observed here
- 2026-09-06T09:04:43.486Z
- Observations recorded
- 2
- Installs (reported upstream)
- 2
- Weekly downloads (upstream)
- 404
- Declared license
- MIT-0
Observation history
2026-11-06T15:44:01.797Z
Fields that differed: license changelog description displayName latestVersion summary
| Field | Before | After |
|---|---|---|
license |
null | "MIT-0" |
changelog |
"v1.0.0 首发：覆盖 SaMD/SiMD 界定与注册路径、IEC 81001-5-1 网络安全、UDI 追溯、RPM 远程监测，附 references 知识库与合规清单。" | "上架标准 v1.0 收尾：简介双语英文在前、补 tags、包内附 llms.txt 并给出直达链接。技能逻辑未改动。" |
description |
"带传感器/APP/云的智能医疗器械（IoMT）合规助手：SaMD+SiMD注册路径、网络安全IEC 81001-5-1、UDI追溯、RPM远程监测。3分钟理清联网器械的NMPA/FDA/MDR合规拼图，输出可提交文档清单与要点。" | null |
displayName |
"智能医疗器械IoMT合规" | "IoMT Compliance（智能医疗器械IoMT合规）" |
latestVersion |
"1.0.0" | "1.0.3" |
summary |
"带传感器/APP/云的智能医疗器械（IoMT）合规助手：SaMD+SiMD注册路径、网络安全IEC 81001-5-1、UDI追溯、RPM远程监测。3分钟理清联网器械的NMPA/FDA/MDR合规拼图，输出可提交文档清单与要点。" | "Compliance guide for connected medical devices that combine sensors, a companion app and a cloud service: it lays out the SaMD and SiMD registration paths, cybersecurity expectati |
Correction
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