{"skill":{"slug":"risk-management-iso14971","displayName":"风险管理专家 (ISO 14971)","summary":"Medical device risk management specialist implementing ISO 14971 throughout product lifecycle. Provides risk analysis, risk evaluation, risk control, and pos...","tags":{"fmea":"1.0.0","iso14971":"1.0.0","latest":"1.0.0","medical":"1.0.0","risk":"1.0.0"},"stats":{"comments":0,"downloads":264,"installsAllTime":1,"installsCurrent":1,"stars":0,"versions":1},"createdAt":1773544877436,"updatedAt":1777526048640},"latestVersion":{"version":"1.0.0","createdAt":1773544877436,"changelog":"初始版本：ISO 14971:2019 医疗风险管理全流程实施专家。提供风险管理计划制定、危害识别（FMEA/FTA/HAZOP）、风险评价（5x5 矩阵）、风险控制（优先级：设计>防护>信息）、剩余风险评估、生产后监控。包含完整的风险分析模板、受益 - 风险分析框架、ALARP 证明方法。","license":"MIT-0"},"metadata":null,"owner":{"handle":"ayangai","userId":"s178a1snn59x5rjce50t9g2np183jxr0","displayName":"张洋","image":"https://avatars.githubusercontent.com/u/12815071?v=4"},"moderation":null}