医疗器械风险管理 BSI培训课件.pptxVIP

22/07/2019医疗器械风险管理ISO14971:2007YY/T0316:2016计利方BSICopyright ? 2019 BSI. All rights reserved1Boundaries: Conflict of interest and expertise限界：利益与专业的冲突BSI can explain: BSI能够说明：?What the regulations require法规的要求是什么?How the requirements are interpreted如何解释要求BSI cannot: BSI不能说明：? Explain how to implement compliant systems within a specificorganization说明如何在特定组织建立投诉系统? Spread best industrial/manufacturing practice that is notavailable in the public domain和您分享在未公开的最佳行业/制造实践1 22/07/2019Boundaries: Conflict of interest and expertise限界：利益与专业的冲突We can teach the regulatory requirements forvigilance but we cannot teach how toimplement a Standard Operating Procedure in aparticular organization我们可以讲解警戒事件汇报的法规要求。但我们不可以教您如何在特定组织实施标准作业程序(SOP)We can teach the principles of post market surveillance but wecannot suggest how to perform it for a specific product line我们可以讲授上市后市场监督原则，但不可以建议如何针对特定产品线执行上市后监督课程内容风险管理标准知识回顾风险管理工具（FMEA、PHA、FTA、HACCP）有源医疗器械的风险管理(IEC6060-1)易用性的风险管理（Usability IEC 62366）软件产品的风险管理（IEC 62304 IEC 80001）生物兼容性的风险管理ISO 10993(GB16886)体外诊断医疗器械安规标准 EN 61010-2-101欧盟对风险管理的特殊要求（EN ISO 14971:2012）??欧盟协调性标准附录Z中的Deviations。风险管理如何满足欧盟法规的要求ISO 14971:2019第三版风险管理标准的更新MDR对风险管理的要求风险管理案例回顾和讨论2 22/07/2019Risk management process 风险管理流程Risk management plan风险管理计划Risk analysis风险分析Risk evaluation风险评估Output输出Risk control风险控制Evaluation of residual risk剩余风险评估Risk management report风险管理报告Production and post-production informationAdapted from EN ISO14971 Clause 3.1生产和生产后信息Who said this? 谁说了这段话“Reports that say that something hasn’thappened are always interesting to me,because, as we know, there are knownknowns; there are things we know weknow.We also know there are known unknowns;that is to say we know there are somethings we do not know.But there are also unknown unknowns –theones we don’t know we don’t know”.3 22/07/2019风险管理也很容易We know we knowWe know we don’t knowWe don’t know we don’t knowWe know we knowwe know we don’t know现有公认技术水平 State of the art:GB 16886 医疗器械生物学评价ISO 10993 Biological evaluati