medical-device-samdSaMD(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。
Install via ClawdBot CLI:
clawdbot install zhaoxinghua09-cell/medical-device-samdLoading skill content… the page will refresh in a moment.
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