体外诊断试剂风险管理探究

Risk Management of In Vitro Diagnostic Reagents

随着经济发展与医疗水平的提高,体外诊断试剂在我国市场需求旺盛,各种体外诊断试剂的研发与应用日新月异,但随之而来的各种风险也频频出现,需要做好其风险分析与研究。因此,在了解医疗器械质量管理与风险管理关系的基础上对体外诊断试剂风险管理的具体情况进行研究,希望能促进其风险管理的有序实施。

With the economic development and the improvement of medical standards,in-vitro diagnostic reagents are in strong demand in the Chinese market.The research and development and application of various in-vitro diagnostic reagents are changing with each passing day.However,various risks that follow frequently appear,and it is necessary to do a good job of risk analysis and research.Therefore,on the basis of understanding the relationship between medical device quality management and risk management,the specific situation of in vitro diagnostic reagent risk management is studied,hoping to promote the orderly implementation of its risk management.