Comparison of the software safety evaluation methods in medical devices.
- Author:
Sicong YU
1
;
Ying PAN
;
Xiping YU
;
Yinfeng ZHU
Author Information
1. Medical Device Registration Department, Shanghai Municipal Food and Drug Administration, Shanghai, 200010. yusicong@smda.gov.cn
- Publication Type:Journal Article
- MeSH:
China;
Equipment Safety;
methods;
Europe;
Quality Control;
Safety Management;
methods;
Software;
United States
- From:Chinese Journal of Medical Instrumentation
2010;34(5):360-364
- CountryChina
- Language:Chinese
-
Abstract:
The article intends to analyze the software safety problems in high-risk medical devices based on the investigation of software R & D Quality control procedures in Shanghai medical device manufacturing enterprises. The idea of improving the software pre-market safety evaluation method in China is also explored through the way of comparing those in U.S. and Europe.
