Study on Influencing Factors of Environmental Testing Quality of Medical Device Manufacturers Clean Workshops.
10.3969/j.issn.1671-7104.2022.01.021
- Author:
Mou LIANG
1
;
Ze XUAN
1
;
Yihui PANG
1
;
Xia WANG
1
;
Huan LIU
1
;
Zhijie JIANG
1
Author Information
1. Beijing Institute for Drug Control, Beijing, 102206.
- Publication Type:Journal Article
- Keywords:
clean workshops;
influence factor;
medical device;
quality control
- MeSH:
Commerce;
Equipment and Supplies;
Reproducibility of Results
- From:
Chinese Journal of Medical Instrumentation
2022;46(1):99-102
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:Improve the quality of testing in medical device manufacturers clean workshops to ensure the authenticity and reliability of testing data.
METHODS:Analyze the problems and influencing factors found in the process of testing of medical device manufacturers clean workshops from 2016 to 2020, and put forward reasonable suggestions to ensure the quality of testing.
RESULTS:In the process of testing, there are six factors that affect the quality of testing, including testing personnel, instruments and equipment, testing consumables, testing methods, testing environment and actual operation.
CONCLUSIONS:To improve the quality of testing, should strengthen the training of testing personnel, continuously improve the testing quality management system, establish an effective information communication mechanism, find out the influencing factors in time, provide objective, real and effective testing data for medical device manufacturing enterprises, and provide technical support for the production and supervision of medical devices.
