Exploration of Application of Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices:Take Artificial Joint Products as Example
Exploration of Application of Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices:Take Artificial Joint Products as Example
Through the effective application of Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices(EP),to continuously improve the corresponding management tools to ensure the safety and effectiveness of medical device in the quality management system,risk management system,evaluation of safety and effectiveness for the supervision departments and manufacturers.The current status of the application of EP and the application issues are analyzed in the study.Take artificial joint products for example,the idea of using EP in quality management system,risk management system and evaluation of safety and effectiveness is investigated,and several thoughts are proposed.Supervision departments should strengthen the unified understanding of EP,develop requirements according to the classification of medical device,and refine specific execution requirements.
关键词
关节假体/质量管理体系/风险管理体系/安全有效性/医疗器械注册申报资料
Key words
artificial joint/quality management system/risk management system/safety and effectiveness/medical device registration information
维普
万方数据