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QSR820 definition

QSR820, also known as 21CFR820, is the abbreviation of the American medical device quality management system Regulations. It is named 21CFR820 because it is located in the Code of Federal Regulations, volume 21, part 820. QSR820 is a quality management system regulation that U.S. (human) medical device manufacturers and foreign (human) medical device manufacturers intend to sell their products into the United States must comply with. Is the basic requirement that most medical devices must comply with before they are marketed in the United States and can be spot-checked at any time afterwards. This kind of spot check is commonly known as FDA factory inspection.

QSR820 services

1) Assessment of the gap between the existing quality management system and QSR 820 standard requirements

2) Overall planning of consultation process, rectification of packaging site, and rectification of documentation system and application

3) General QSR 820 training for relevant personnel

4) QSR 820 special training for key personnel

5) Based on the content of the earlier stages, the consultant and relevant personnel of the enterprise will repair the file system together

6) Implement and apply the revised file system

7) To check the effectiveness of the system, arrange our company's reviewers to conduct mock audit before FDA's audit

8) Accompany FDA to audit the factory

9) Assist the enterprise to rectify the nonconformities proposed by FDA until FDA closes the nonconformities

QSR820 definition

QSR820 services

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