The company has established a quality management system in accordance with ISO13485:2016 "Requirements for the Use of Medical Device Quality Management Systems in Regulations", "Medical Device Production Quality Management Standards", and relevant requirements of EU MDR and US QSR820. The company has obtained ISO13485 quality system certification CE certificate and EU product certification, and has obtained 12 domestic medical device product registration certificates, 16 medical device CE certificates, and 18 medical device FDA registrations. The company's quality management system has been approved by multiple health departments, and quality control can be smoothly passed through both document audits and on-site inspections.