摘要
本文通过对医疗器械风险管理与风险管理报告作用的论述,提出风险管理报告在医疗器械评价系统中的作用的论点和风险管理报告应具备分析充分性、控制彻底性和风险逻辑关系的论点。
Through discourse the use of medical device risk management and risk management report,provide the argument that the use of risk management report in the medical device evaluation system and the risk management report should have adequacy,complete control and risk logical relationship.
出处
《中国医疗器械信息》
2011年第11期5-9,共5页
China Medical Device Information
关键词
医疗器械
风险管理
评价
medical device
risk management
evaluation