摘要
以新版ISO 9001质量管理体系有关知识管理的要求为出发点,通过分析医疗器械审评核查知识特点、知识分类以及知识管理的内容和作用,提出了应用知识管理的方法,结合信息化手段,构建医疗器械审评核查知识管理体系的方法和相关建议。
Based on the requirements of knowledge management in the new version of ISO 9001 quality management system, this paper analyzes the characteristics, classification, contents and functions of knowledge management in medical device evaluation and inspection, and puts forward the methods and relevant suggestions of applying knowledge management and combining information means to build the knowledge management system of medical device evaluation and inspection.
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1期4-5,33,共3页
China Medical Device Information
基金
上海市药品监督管理局课题研究项目（项目编号：KT-201906060212）
关键词
医疗器械
审评核查
知识管理
medical devices
technical evaluation and field inspection
knowledge management
