SaMD软件医疗器械专家
SaMD（Software as a Medical Device）软件即医疗器械专题技能——SaMD 判定与 IMDRF N12 风险分类（I-IV 类）+ IEC 62304 软件生命周期（A/B/C 级）+ FDA 软件三级关注（Major/Moderate/Minor）+ MDR 软件分类规则 11 + 网络安全（MDCG 2019-16、FDA 网络安全指南、SBOM）评估清单。独立软件/含软件器械注册申报的软件文档怎么搭、分类怎么定、网络安全怎么做，一站理清，附官方入口直达。
as observed 2026-10-17T20:48:50.018Z- Identifier
medical-device-samd- Source
- ClawHub
- Version observed
- 1.0.0
- Source repository
- not published
- Repository observation
- No source repository listed
- First observed here
- 2026-08-28T22:06:28.212Z
- Observations recorded
- 2
- Installs (reported upstream)
- 0
- Weekly downloads (upstream)
- 325
- Declared license
- MIT-0
Observation history
2026-10-17T20:48:50.018Z
Fields that differed: license description
| Field | Before | After |
|---|---|---|
license |
null | "MIT-0" |
description |
"SaMD（Software as a Medical Device）软件即医疗器械专题技能——SaMD 判定与 IMDRF N12 风险分类（I-IV 类）+ IEC 62304 软件生命周期（A/B/C 级）+ FDA 软件三级关注（Major/Moderate/Minor）+ MDR 软件分类规则 11 + 网络安全（MDCG 2019-16、FDA | null |
Correction
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