The function of medical device products is reflected through testing activities, in the production process for semi-finished products in advance control, unqualified can also be reworked in advance to achieve qualified, the final test is the factory test can also be called a finished product testing, once unqualified it is too late. Various products are not the same, find the key processes and special process control points, control.
Medical devices are instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials and other similar or related items used directly or indirectly for the human body, including the required computer software. Medical devices include medical equipment and medical supplies.