ISO13485 Medical Device Quality Management System

ISO13485, also known as "Medical Device Quality Management System for Regulatory Requirements" in Chinese, is a special product for saving lives, treating diseases, and preventing illnesses. It is not enough to regulate medical devices according to the general requirements of ISO9001 standard. Unlike ISO9001 standard, ISO13485 is a management standard applicable to regulatory environments: from its name, it is clearly used for regulatory quality management system requirements. Medical devices are not only ordinary marketed products operating in a commercial environment internationally, but also subject to supervision and management by national and regional laws and regulations, such as the FDA in the United States, the MDD (European Medical Device Directive) in the European Union, and China's Medical Device Regulation. Therefore, this standard must be subject to legal constraints, operate in a regulatory environment, and fully consider the risks of medical device products, requiring risk management throughout the entire process of medical device product implementation. So besides specific requirements, it can be said that ISO13485 is actually ISO9001 in the medical device regulatory environment.