ISO13485:2003 is the full name of "Medical device quality management system for regulatory requirements", is applicable to the regulatory environment of management standards: from the name is clearly used for regulatory quality management system requirements。In the international market, medical devices are not only general listed commodities operating in a commercial environment, but also subject to the supervision and management of national and regional laws and regulations, such as FDA in the United States, MDD (European Union Medical Device Directive) in the European Union, and China's Medical Device Regulatory Regulations.。Therefore, the standard must be subject to legal constraints, operate in a regulatory environment, and must fully consider the risk of medical device products, requiring risk management in the whole process of the realization of medical device products。