[Discourse of requirement for facility & environment in medical device quality system].
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.
Shanghai NQA Certification Co., Ltd, Shanghai, 200122. 13094809949@163.com
Hongguang
H
Lü
D018795:Device Approval; D004784:Environmental Monitoring; D007221:Industry; D011786:Quality Control