Technical File STED Expert（医械技术文件STED专家）
Medical device technical documentation & STED skill — IMDRF STED 6-chapter structure, EU MDR Annex II/III, FDA 510(k) Summary/eSTAR, CN submission files (Notice 121/122), JP technical files comparison & writing points with official references. 医疗器械技术文件与STED专题——IMDRF STED 六章、MDR Annex II/III、
as observed 2026-11-06T15:44:01.797Z- Identifier
medical-device-techfile-sted- Source
- ClawHub
- Version observed
- 1.0.3
- 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)
- 1
- Weekly downloads (upstream)
- 452
- 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 |
"首版发布：医疗器械合规专题技能，含 references 知识库 + 安全稳定性实测 + 权属证据包" | "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 |
"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 | null |
displayName |
"医械技术文件STED专家" | "Technical File STED Expert（医械技术文件STED专家）" |
latestVersion |
"1.0.0" | "1.0.3" |
summary |
"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 | "Medical device technical documentation & STED skill — IMDRF STED 6-chapter structure, EU MDR Annex II/III, FDA 510(k) Summary/eSTAR, CN submission files (Notice 121/122), JP techn |
Correction
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