Discourse of requirement for facility & environment in medical device quality system / 中国医疗器械杂志
Chinese Journal of Medical Instrumentation
;
(6): 218-221, 2012.
Article
in Chinese
| WPRIM
| ID: wpr-342967
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.
Full text:
Available
Index:
WPRIM (Western Pacific)
Main subject:
Quality Control
/
Environmental Monitoring
/
Device Approval
/
Industry
Language:
Chinese
Journal:
Chinese Journal of Medical Instrumentation
Year:
2012
Type:
Article
Similar
MEDLINE
...
LILACS
LIS