Discussion on the Building of Post Market Risk Analysis Method in Hemodialysis Device
10.3969/j.issn.1671-7104.2014.05.016
- VernacularTitle:血液透析装置上市后风险分析方法构建探讨
- Author:
Honglei XU
1
;
Xiaolong PENG
;
Xiaojun TIAN
;
Peilian WANG
Author Information
1. 国家食品药品监督管理局广州医疗器械质量监督检验中心
- Keywords:
hemodialysis device;
post market;
risk analysis;
risk identification;
risk estimation
- From:
Chinese Journal of Medical Instrumentation
2014;(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 wel.
