Abstract:Through introducing the construction of medical device clinical trial management system in Inner Mongolia People’s Hospital, this paper is aimed at further standardizing the medical device clinical trial behaviors and enhancing the level of medical instrument clinical trials, thus ensuring the scientificalness and reliability of clinical trials. This paper also provides some references on obtaining independent certification for medical device clinical trial institutions.
朱丹丹,王学军,李伟. 我院医疗器械临床试验管理体系的构建[J]. 中国医疗设备, 2015, 30(1): 122-124.
ZHU Dan-dan, WANG Xue-jun, LI Wei. Construction of Medical Device Clinical Trial Management System in Our Hospital. China Medical Devices, 2015, 30(1): 122-124.