Abstract：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.
张晓燕，高关心，王学军，边立军，朱丹丹，李岳飞. 我院医疗器械临床试验机构质量监管体系构建的探讨[J]. 中国医疗设备, 2020, 35(4): 131-134.
ZHANG Xiaoyan, GAO Guanxin, WANG Xuejun, BIAN Lijun, ZHU Dandan, LI Yuefei. Discussion on the Construction of Quality Supervision System of Clinical Test
Institution of Medical Device in Our Hospital. China Medical Devices, 2020, 35(4): 131-134.
