Enterprise quality management organization or quality management personnel shall perform the following duties:
(1) Organize the development of quality management system, guide and supervise 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 device business related laws and regulations and other relevant provisions to implement dynamic management;
(3) Supervise relevant departments and post personnel to carry out Medical device business related laws, regulations and other relevant provisions, the implementation of dynamic management;
(C) supervise the relevant departments and positions in the implementation of medical equipment regulations and rules and this specification;
(D) is responsible for medical device suppliers, products, purchasers qualification audit;
(E) is responsible for the identification of unqualified medical devices, unqualified medical devices to the Handling process supervision;
(F) is responsible for medical device quality complaints and quality incident investigation, handling and reporting;
(G) organization verification, calibration of relevant facilities and equipment;
(H) organization of medical device adverse event collection and reporting;
(I) responsible for the management of medical device recall;
(J) organization of the Entrusted to transport the carrier transport conditions and quality assurance capabilities of the audit;
(xi) organization or assist in quality management training;
(xii) other should be performed by the quality management organization or quality management personnel duties.