摘要
质量管理体系对于提高效率、推动可持续发展有重要意义。该文就医疗器械技术审评质量管理体系相关定义、构建原则、文件控制和测量分析改进、体系构建等方面进行了介绍和探讨,以期能为相关研究人员提供参考。
The quality management system is of great significance for improving efficiency and promoting sustainable development.This article introduces and discusses the related definitions,construction principles,improvements of document control and measurement analysis,and system construction,etc.of quality management system for evaluation of medical devices in order to provide references for relevant researchers.
作者
张世庆
钱虹
李耀华
ZHANG Shiqing;QIAN Hong;LI Yaohua(Center for Medical Device Evaluation,CFDA,Beijing,100081;Center for Certification&Evaluation,SHFDA,Shanghai,200020)
出处
《中国医疗器械杂志》
2018年第4期276-278,共3页
Chinese Journal of Medical Instrumentation
基金
国家重点研发计划课题(2016YFB1101105)
关键词
医疗器械
技术审评
质量管理体系
medical devices
evaluation
quality management system