Discussion on the building of post market risk analysis method in hemodialysis device.
- Author:
Honglei XU
1
;
Xiaolong PENG
;
Xiaojun TIAN
;
Peilian WANG
Author Information
1. Guangzhou Medical Instruments Quality Surveillance and Inspection Center of State Food and Drug Administration, Guangzhou. xhl-88@163.com
- Publication Type:Journal Article
- MeSH:
Government Regulation;
Renal Dialysis;
instrumentation;
standards;
Research Design;
Risk Assessment;
Risk Management
- From:
Chinese Journal of Medical Instrumentation
2014;38(5):371-374
- CountryChina
- Language:Chinese
-
Abstract:
This paper discussed the building of post market risk analysis method in hemodialysis device from the point of government supervision. By proposing practical research methods for post market risk identification and estimation on hemodialysis device, providing technical guidance for government to put risk management of hemodialysis device into effect, and offering reference for enterprises to carry out post market risk evaluation on their products as well.
