Exploration on the regulation mode of medical device quality and safety on a life-circle basis.
- Author:
Hong-Liu YU
1
;
Xing-San QIAN
Author Information
1. University of Shanghai for Science and Technology, Shanghai 200093.
- Publication Type:Journal Article
- MeSH:
Device Approval;
Equipment Design;
Equipment Safety;
Equipment and Supplies;
standards;
Government Regulation;
Humans;
Models, Theoretical;
Product Surveillance, Postmarketing;
methods;
Quality Control;
Safety Management
- From:Chinese Journal of Medical Instrumentation
2006;30(2):120-133
- CountryChina
- Language:Chinese
-
Abstract:
A new conception of the life-circle state regulation for medical device's quality and safety is analyzed in the paper. The life-circle model and its corresponding regulation methods are discussed according to the characteristics of medical devices. Then, the regulation mode for application quality and safety of medical devices in a life-circle regulation system is explored.
