As medical devices are special products for saving lives and healing injuries, preventing and treating diseases, they are not only general listed products operating in the commercial environment in the world, but also subject to the supervision and management of national and regional laws and regulations, such as FDA of the United States, MDD of the European Union (European Union Medical Device Directive), and the regulation on the supervision and management of medical devices of China. Therefore, it is not enough for medical devices to be standardized only according to the general requirements of ISO 9000 standard. Its applicable standards must be subject to legal constraints and operate in a regulatory environment. At the same time, the risks of medical devices must be fully considered, and risk management is required in the whole process of the realization of medical devices. For this reason, ISO has issued ISO 13485 standard (equivalent to yy/t0287 standard by the State Food and Drug Administration), which puts forward special requirements for the quality management system of medical device manufacturers, and plays a good role in promoting the quality of medical devices to be safe and effective.

The full name of the ISO 13485 standard is "Medical device-quality management system-requirements for regulatory". Developed by the SCA/TC221 Technical Committee for Standardization of Quality Management and General Requirements for Medical Devices, this standard is an independent standard based on ISO 9001 and is a management standard applicable in the regulatory environment, which clearly defines the quality management system requirements used for regulations. So in addition to the special requirements, it can be said that the ISO 13485 standard is actually ISO 9001 in the context of medical device regulations. The standard specifies the quality management system requirements for the relevant organizations, but is not a guide for the implementation of the ISO 9001 standard in the medical device industry.