Medical device business enterprise quality management personnel need to fulfill what duties?

Yanxing Medical: According to the basic requirements of medical device business quality management, medical device business enterprise quality management personnel need to perform the following duties:

1. Organize the development of quality management system, guidance, supervision of the implementation of the system, and the implementation of the quality management system for inspection, correction and continuous improvement;

2. Responsible for the collection of medical devices related to business Laws, regulations and other relevant provisions, the implementation of dynamic management;

3. Supervise the relevant departments and positions to implement the medical device regulations and rules and quality management standards for the operation of medical devices;

4. Responsible for the qualification of medical device suppliers, products, purchasers of qualifications;

5. Responsible for the confirmation of unqualified medical devices, and the process of dealing with the unqualified medical device Supervision;

6. Responsible for medical device quality complaints and quality incident investigation, handling and reporting;

7. Organization of verification, calibration of relevant facilities and equipment;

8. Organization of medical device adverse event collection and reporting;

9. Responsible for the management of the recall of medical devices;

10. Organization of the entrusted transport carrier Transportation conditions and quality assurance capabilities of the audit;

11. Organize or assist in carrying out quality management training.