ISO13485 is a quality management system standard applicable to the regulatory environment of medical devices. Its full name is "Requirements for Medical Device Quality Management Systems for Regulatory Purposes". The definition of ISO13485 certification is that ISO13485 is a medical device quality management system standard developed by the Organization for Standardization (ISO), also known as medical device quality management system certification. This certification requires companies to establish a complete quality management system, covering the design, development, and production of medical devices