摘要
以医疗器械审评改革要求为背景,结合医疗器械技术审评工作实际,探讨应用ISO9001过程方法建立医疗器械技术审评质量管理体系,并通过运用PDCA循环方法和风险管理理念加强审评过程管理,提出了具体的管理措施。
Based on the requirements of medical device evaluation reform and the practice of medical device technical evaluation,this paper discusses the application of ISO 9001 process method to establish the quality management system of medical device technical evaluation,and puts forward relevant measures and suggestions by using PDCA cycle method and risk management concept to strengthen the evaluation process management and improve the quality control.
作者
刘群
LIU Qun(Shanghai Food and Drug Administration Certification&Evaluation Center,Shanghai 200020)
出处
《中国医疗器械信息》
2020年第7期6-8,共3页
China Medical Device Information
关键词
医疗器械
技术审评
过程方法
medical device
technical evaluation
process method
