摘要
目的探讨适宜我院医疗器械临床试验机构质量监管体系构建的相关内容,提高项目管理质量。方法总结在医疗器械临床试验过程中存在的问题,分析问题的原因。结果结合我院运行特点,在资质审核、项目审核、试验过程管理、财务管理及文件管理等方面,提出对应的监管体系建设意见。结论本体系的构建能够较大程度的保障我院医疗器械临床试验项目管理的规范化,同时提高项目管理的效率。
Objective To explore the content of quality supervision system for medical device clinical test institutions in our hospital and improve the quality of project management.Methods The problems existing in the clinical test of medical devices were summarized and the causes were analyzed.Results According to the characteristics,suggestions on the construction of the corresponding supervision system were put forward in the aspects of qualification audit,project audit,test process management,financial management and document management.Conclusion The construction of this system can ensure the standardization of clinical trial project management of medical devices in our hospital and improve the efficiency of project management.
作者
张晓燕
高关心
王学军
边立军
朱丹丹
李岳飞
ZHANG Xiaoyan;GAO Guanxin;WANG Xuejun;BIAN Lijun;ZHU Dandan;LI Yuefei(Department of Medical Engineering,People’s Hospital of Inner Mongolia Autonomous Region,Hohhot Inner Mongolia 010017,China)
出处
《中国医疗设备》
2020年第4期131-134,共4页
China Medical Devices
关键词
医疗器械
临床试验机构
质量监管
体系建设
medical device
clinical trial institution
quality control
system construction
