How to Integrate GLP into Quality Management of Biological Tests of Medical Devices.
10.3969/j.issn.1671-7104.2018.04.015
- Author:
Jian XIANG
1
;
Lifeng YANG
1
;
Shenghui TIAN
1
;
Suilan CAO
1
;
Lin YAN
1
Author Information
1. Guangdong Medical Devices Quality Surveillance and Test Institute, Guangzhou, 510080.
- Publication Type:Journal Article
- Keywords:
GLP;
biological tests;
medical devices
- MeSH:
China;
Equipment Safety;
Equipment and Supplies;
Reproducibility of Results
- From:
Chinese Journal of Medical Instrumentation
2018;42(4):282-285
- CountryChina
- Language:Chinese
-
Abstract:
Biological tests of medical devices is an important part to evaluate its biological safety. Good quality management of the test is a powerful guarantee to ensure the authenticity, integrity and reliability of the test results. This paper is based on the biological tests of medical devices, compares GLP and ISO/IEC 17025 which is widely used in China medical device testing institutions, describes the implementation of the GLP reference points to strengthen the quality management of biological tests of medical devices under the ISO/IEC 17025 system, to provide reference for quality management of medical device testing institutions.
