Discourse of requirement for facility & environment in medical device quality system.
- Author:
Hongguang LÜ
1
Author Information
1. Shanghai NQA Certification Co., Ltd, Shanghai, 200122. 13094809949@163.com
- Publication Type:Journal Article
- MeSH:
Device Approval;
Environmental Monitoring;
Industry;
Quality Control
- From:
Chinese Journal of Medical Instrumentation
2012;36(3):218-221
- CountryChina
- Language:Chinese
-
Abstract:
Requirement for facility and environment of FDA, regulation of China medical device Quality System, Europe medical device Directive and ISO13485 standard are introduced. The comparison is made to help domestic medical device industry understand the regulation requirement.
