Medical device software requirements and evaluation.
- Author:
Tao HE
1
,
2
;
Yi WU
;
Kun DU
Author Information
1. Zhejiang Institute for the Control of Medical Device, Hangzhou, Zhejiang,
2. zjhetao@tom.com
- Publication Type:Journal Article
- MeSH:
Equipment Safety;
Equipment and Supplies;
Software;
Software Validation
- From:
Chinese Journal of Medical Instrumentation
2011;35(5):379-382
- CountryChina
- Language:Chinese
-
Abstract:
This paper introduces the safety and effectiveness requirements of medical device software. And it discusses the methods on evaluating medical device software from two aspects, the design and development process of the software and software products.
