摘要
知识管理是组织系统管理信息与知识,最终使知识不断创新的重要方法。知识管理包括知识的获取、共享和使用等阶段,最终达到以知识为生产要素,提高组织工作效能等目的。医疗器械技术审评的核心工作为典型的知识工作,知识管理体系对于审评机构提高工作效率、促进人才培养、提升管理水平和服务质量意义重大。简要介绍上海市食品药品监督管理局认证审评中心医疗器械技术审评知识管理体系的构架设想,为相关机构开展医疗器械技术审评知识管理工作提供参考。
Knowledge management is an important method for the organization to manage information and knowledge systematically and make knowledge innovate continuously. Knowledge management includes the stages of knowledge acquisition, sharing and use, and finally achieves the goal of taking knowledge as the production factor and improving work efficiency in an organization. The core work of technical evaluation of medical devices is typical knowledge work, and the knowledge management system is of great significance to the review agency in improving work efficiency, promoting talent training, improving management level and service quality. This study briefly introduces the framework of the knowledge management system of medical device technical evaluation in the Center for Certification and Evaluation, SHFDA, and provides reference for relevant organizations to carry out knowledge management of medical device technical evaluation.
作者
钱虹
孙果梅
QIAN Hong;SUN Guomei(Center for Certification and Evaluation,SHFDA,Shanghai,200020)
出处
《中国医疗器械杂志》
2020年第4期331-333,共3页
Chinese Journal of Medical Instrumentation
基金
上海市药品监督管理局课题研究项目(KT-201906060212)。
关键词
知识管理
知识
知识框架
医疗器械技术审评
knowledge management
knowledge
knowledge framework
technical evaluation of medical devices
