How to implement and comply with the quality management standard for the production and operation of medical devices

1, with the production of medical devices and production sites, environmental conditions, production equipment and professional and technical personnel

2, the production of medical devices to carry out quality inspection of the organization or full-time inspectors and inspection equipment

3, there is to ensure that the quality of medical devices management system

4, with the production of medical devices and the appropriate after-sales service Ability

5, is in line with the product development, production process documentation requirements

The above conditions are the basic conditions for medical device manufacturers, but also the regulatory authorities based on the quality management standard for the production of medical devices to carry out on-site verification of production licenses core content