中国药业2016，Vol.25Issue(2)：13-15,16,4.
医疗器械技术审评质量风险分析与控制
Risk Analysis and Control of Medical Device Technical Evaluation
周冬 1张弦 1杨士友1
作者信息
- 1. 安徽省食品药品审评认证中心，安徽 合肥 230051
- 折叠
摘要
Abstract
Objective To study the risk control of on medical device technical evaluation. Methods According to the principle of risk management,5 factors that might influence the quality of technical evaluation were analyzed,namely personnel management,system of registered regulations,system management,information management and the degree of credit of the enterprise. Effective measures to con-trol risks of technical evaluation was promoted to eliminate and reduce quality risks of technical evaluation,and to improve the quality of technical evaluation. Results and Conclusion Risk analysis can effectively control the quality of technical evaluation. The provincial technical evaluation institution should prevent risk and control the quality by continous improvement of quality management system,as well as strengthening,institutional capacity building and improving working efficiency.关键词
医疗器械/技术审评/风险管理Key words
medical device/technical evaluation/risk management分类
医药卫生引用本文复制引用
周冬,张弦,杨士友..医疗器械技术审评质量风险分析与控制[J].中国药业,2016,25(2):13-15,16,4.
