medical-device-techfile-sted医疗器械技术文件(Technical Documentation)与 STED(Summary Technical Documentation)专题技能——IMDRF STED 六章结构 + 欧盟 MDR Annex II/III 技术文档 + 美国 510(k) Summary/eSTAR + 中国注册申报资料(121/122 号公告)+ 日本技术资料对照;附技术文档结构与差异对照表、各模块撰写要点与官方入口直达。以 STED 为骨架写一套、映射各国章节,最大化复用。
Install via ClawdBot CLI:
clawdbot install zhaoxinghua09-cell/medical-device-techfile-stedLoading skill content… the page will refresh in a moment.
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