Strengthen the application of laws and regulations in the quality management system of medical devices. According to the relevant data of medical device management regulations, the purpose of medical device quality management system used in the training of regulatory requirements is to strengthen the application of regulations in medical device quality management system. Medical devices refer to instruments, equipment, appliances, in-vitro diagnostic reagents and calibrations, materials and other similar or related items directly or indirectly used in human body, including required computer software.