医疗器械临床试验风险管理思考与建议
Thoughts and Suggestions on Risk Management of Medical Device Clinical Trials
王健 1冯巧巧 1刘珊珊1
作者信息
- 1. 山东省食品药品审评查验中心,济南 250014
- 折叠
摘要
目的:提高医疗器械临床试验各参与方的风险意识,提升质量管理水平,为构建医疗器械科学监管提供保障和技术支撑.方法:结合多年医疗器械临床试验监管经验和检查资料,分析医疗器械临床试验各个环节的风险因素,提出纠正预防措施.结果 与结论:医疗器械临床试验各产品之间风险差异大,良好的方案设计较困难,对主要研究者的依赖性强,目前的监管模式单一.加强全方位的风险管理,将有效提升医疗器械临床试验质量管理水平,促进整个医疗器械行业的健康快速发展.
Abstract
Objective:To improve the risk awareness of all participants in clinical trials of medical devices,improve quality management level,to provide guarantee and technical supports for the construction of scientific supervision of medical devices.Methods:Combined with years of medical device clinical trial supervision experience and inspection data,the risk factors of all aspects of clinical trials of medical devices were analyzed,and corrective and preventive measures were proposed.Results and Conclusion:There were great differences in risks among products in clinical trials of medical devices.It was difficult to design a good scheme,and the dependence on the main investigator was strong.The current regulatory model was single.Strengthening all-round risk management will effectively improve the quality management level of medical device clinical trials and promote the healthy and rapid development of the entire medical device industry.
关键词
医疗器械/临床试验/风险管理/质量管理/科学监管Key words
medical device/clinical trials/risk management/quality control/scientific supervision引用本文复制引用
出版年
2024
NETL
NSTL
万方数据