Exploring how to Improve the Quality Control of Medical Instrument Clinical Trials
10.3760/cma.j.issn.1006-1924.2015.01.002
- VernacularTitle:探讨如何加强医疗器械临床试验的质量控制
- Author:
Shan JING
;
Huaying FAN
;
Lijue WANG
;
Hao WANG
;
Yulan LIU
- Publication Type:Journal Article
- Keywords:
Medical Instrument;
Clinical Trial;
Quality Control
- From:
Chinese Journal of Medical Science Research Management
2015;28(1):5-7,12
- CountryChina
- Language:Chinese
-
Abstract:
Objective To improve the quality of medical device clinical trial.Methods To analyze medical device clinical trials conducted in our hospital from 2006 to 2010,and proposed the strategy to strengthen medical device clinical trial management.Results Most of the medical devices clinical trials were class Ⅲ medical devices clinical validation in our hospital,Surgical departments undertook most of the clinical trials.Until July 2013,49 trials were done only 56％ of undertake the project.96％ of completed trials were approved for medical device registration certificate.Conclusions The quality of clinical trials must be improved,andthe quality control process in medical device clinical trial should be reinforced.
