Medical device production workshop site need to set up a nonconforming products area?

Required 1, the person in charge of the enterprise should have secondary school (high school) or above, familiar with the supervision and management of medical devices and medical devices supervision and management of laws and regulations and the operation of medical device products.

2, the quality of business enterprises should have college education or intermediate title or above, familiar with the supervision and management of medical devices and medical devices supervision and management of laws and regulations and the quality of medical device products operating standards, after training and meet the assessment requirements.

3, the enterprise should be set up with the scale of operation and business scope of the quality management and inspection (verification) organizations, the exercise of quality management and quality verification functions. Enterprises should have a special quality inspection site and the corresponding testing equipment and measuring instruments, and in the validity of the use.

4, the enterprise should be equipped with relevant professional after-sales service personnel, with the scale of operation and business varieties appropriate maintenance and other after-sales service capabilities, or agreed by the third party to provide technical support.