Risk Management Expert（医械风险管理专家）
Medical device risk management skill — ISO 14971:2019 / GB/T 42062-2022 6-step process, hazard identification checklists, risk matrix & acceptability criteria, risk management report framework, global standard mapping with official references. 医疗器械风险管理专题——ISO 14971/GB/T 42062 六步流程实操、危害识别清单、风险矩阵与
as observed 2026-11-06T15:44:01.797Z- Identifier
medical-device-risk-management- 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)
- 428
- 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 |
"医疗器械风险管理（ISO 14971:2019 / GB/T 42062-2022）专题技能——六步风险流程实操（风险分析→评价→控制→综合剩余风险→报告→生产后反馈）+ 危害识别清单 + 风险矩阵与可接受准则 + 风险管理报告框架。每份医械注册案卷的必备文件，审评首先看的\"风险是否识别评价控制\"，一站拿到可落地的模板与全球标准对照（含 FDA 认可共 | null |
displayName |
"医械风险管理专家" | "Risk Management Expert（医械风险管理专家）" |
latestVersion |
"1.0.0" | "1.0.3" |
summary |
"医疗器械风险管理（ISO 14971:2019 / GB/T 42062-2022）专题技能——六步风险流程实操（风险分析→评价→控制→综合剩余风险→报告→生产后反馈）+ 危害识别清单 + 风险矩阵与可接受准则 + 风险管理报告框架。每份医械注册案卷的必备文件，审评首先看的\"风险是否识别评价控制\"，一站拿到可落地的模板与全球标准对照（含 FDA 认可共 | "Medical device risk management skill — ISO 14971:2019 / GB/T 42062-2022 6-step process, hazard identification checklists, risk matrix & acceptability criteria, risk management rep |
Correction
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