浅议风险管理在医疗器械性能评价过程的应用

Discussions on the application of risk management in the performance evaluation of medical device

风险管理在医疗器械性能评价过程中具有重要作用,应重视医疗器械全生命周期进行风险的识别、控制。同时风险管理与性能评价具有很强的关联性,应围绕风险要素构建性能评价体系,同时利用性能评价体系实现风险的精准控制。鉴于风险管理在医疗器械性能评价过程应用的重要性,各国医疗器械监管机构在监管科学研究中加强了风险管理在医疗器械性能评价过程的应用研究。

Risk management plays an important role in performance evaluation of medical devices,the identification and control of its risks should be carried out throughout its whole life cycle.Meanwhile the risk management has a strong correlation with the performance evaluation,which can build based on risk factors,and can be utilized to accurate control of risks.Due to the importance in the process of medical device evaluation,national regulators emphasized on the research and application of risk management in medical device regulatory science research.