What are the requirements for personnel of companies operating in vitro diagnostic reagents?

1. In order to strengthen the quality management of medical device operations, standardize the operation and management of medical devices, and ensure the safety and effectiveness of medical devices, in accordance with the "Regulations on the Supervision and Administration of Medical Devices" and the "Measures for the Supervision and Administration of Medical Device Operations" and other regulations Regulations stipulate and formulate this specification.

2. Medical device operating enterprises should take effective quality control measures in the procurement, acceptance, storage, sales, transportation, after-sales service and other aspects of medical devices to ensure the quality and safety of products during the operation process.

3. The person in charge of quality of the enterprise is responsible for the quality management of medical devices and should independently perform his duties. He has the power to adjudicate the quality management of medical devices within the enterprise and assume corresponding quality management responsibilities. Extended information

The enterprise quality management organization or quality management personnel shall perform the following duties:

1. Organize the formulation of the quality management system, guide and supervise the implementation of the system, and supervise the implementation of the quality management system. Check, correct and continuously improve the implementation;

2. Responsible for collecting laws, regulations and other relevant provisions related to medical device operations, and implement dynamic management;

3. Supervise relevant departments and personnel on the job to implement the regulations, rules and regulations of medical devices and this specification;

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

5. Responsible for not Confirmation of qualified medical devices and supervision of the handling process of unqualified medical devices;

6. Responsible for the investigation, handling and reporting of medical device quality complaints and quality accidents.

Baidu Encyclopedia-Medical Device Operation Quality Management Standards