医疗器械上市后安全性监测框架模式的构建实例研究

Research on the Lssues in the Process of Post-market Surveillance for Medical Devices Based on the Typical Case Analysis

针对心脏瓣膜典型案例,围绕信息收集、分析评价及控制环节存在的问题及可借鉴的经验进行访谈,剖析医疗器械上市后安全性监测过程中可能存在的问题,并提出改进建议。

Regarding the information collected, analysis and actions that have been taken, the issues in the process of the Postmarket Surveillance for Medical Device were analyzed, and some suggestions were given at the same time.