Some companies still need continuous improvement after obtaining ISO13485 certification. By introducing a continuous improvement cycle of quality management system, enterprises can achieve higher product quality and management efficiency. Many successful enterprises have already demonstrated the implementation of ISO13485 certification。。ISO standards are internationally recognized, and quality management system certification can promote product entry into the global market. Quality management system certification is also essential in some non EU countries; 4. Ensure that medical devices comply with regulations and their safety and quality meet market expectations。