The full English name of mdsap is medical device single audit program. The full Chinese name is a single audit procedure for medical devices. It is one of the coordination projects of imdrf. Imdrf (international medical device regulator Forum) is an international coordinating organization for medical device regulation established in 2012 by the medical device regulators of the United States, the European Union, Australia, Brazil, Canada and Japan on the basis of the original gthf (global medical device regulation coordination organization).

SO9001 quality management system certification standard is a summary of the development of management theory and management practice in many countries, especially developed countries. It embodies a management philosophy and quality management method and mode, and has been adopted by more than 100 countries and regions in the world.

ISO13485 medical device quality management system certification is an important basis for medical devices to meet the requirements of most national laws and regulations, and it is also the embodiment of your commitment to meet customer requirements.