摘要
归纳总结了生产企业医疗器械风险管理的误区,研究分析了其产生原因。针对医疗器械生产企业普遍存在的风险管理认识模糊、流于形式等现象,从技术审评角度提出了提高上市门槛,加大机会成本,制定指南、加强培训及人才培养等提高生产企业医疗器械风险管理意识和风险管理实效的方法和建议。
The misunderstanding in the risk management of medical device manufacturers were summarized, and then analyzed for its causes. Some countermeasures were put forward to eliminate the limitations of the manufacturers in risk management, including increasing the requirement for listed enterprise, enhancing opportunity cost, developing guidance,strengthening personnel training and etc.
出处
《医疗卫生装备》
CAS
2016年第3期135-137,140,共4页
Chinese Medical Equipment Journal
关键词
医疗器械
风险管理
生产企业
产品注册
机会成本
medical device
risk management
manufacturing enterprise
product registration
opportunity cost
