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[Introduction of Quality Management System Audit in Medical Device Single Audit Program]
Jing Wen1, Jiangyi Xiao1, Aijun Wang1
1Center for Food and Drug Inspection of CFDA, Beijing, 100061.
Abstract:
The audit of the quality management system in the medical device single audit program covers the requirements of several national regulatory authorities, which has a very important reference value. This paper briefly described the procedures and contents of this audit. Some enlightenment on supervision and inspection are discussed in China, for reference by the regulatory authorities and auditing organizations.
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