摘要
风险管理贯穿于医疗器械监管的全过程,对在用医疗器械也十分必要。文在分析在用医疗器械风险管理的现状基础上,对医疗器械使用环节风险管理的主体、参与者及切入点等重要内容进行了思考。
Risk management penetrate the entire process of medical device regulation, and it is also very necessary for medical devices in use. Based on the analyzing of the status of risk management for medical devices, this paper discusses the principal, participants and entry point of risk management for medical devices.
出处
《中国医疗器械杂志》
CAS
2012年第2期128-132,共5页
Chinese Journal of Medical Instrumentation
基金
上海市教育委员会科研创新项目资助(11YS294)
关键词
在用医疗器械
风险管理
全过程监管
全寿命管理
the used medical devices, risk management, overall-process supervision, life-cycle management
