medical-device-risk-management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 认可共识标准、EU 协调标准、日本 JIS T 0304）。
Install via ClawdBot CLI:
clawdbot install zhaoxinghua09-cell/medical-device-risk-managementGrade Fair — based on market validation, documentation quality, package completeness, maintenance status, and authenticity signals.
Potentially destructive shell commands in tool definitions
curl \| bashCalls external URL not in known-safe list
https://clawhub.ai/user/zhaoxinghua09-cellAudited Sep 11, 2026 · audit v1.0
Usage Guide
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Scored Sep 11, 2026
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