Shanghai Maxflex Obtained ISO 13485 Quality Management System Certification

Good news! With the efforts of all members of Maxflex in Shanghai, Maxflex's Shanghai factory successfully obtained the ISO 13485 quality management system certification on June 27, 2023. ISO 13485 is an international standard for certifying quality management systems for medical devices. The standard requires medical device manufacturers or suppliers to establish, implement, and maintain a quality management system in compliance with relevant regulations and technical requirements to ensure the quality and safety of their products. This certification signifies that our quality management system meets international standards and our products are more mature and stable, which has significant implications for the development of our company.

1. Global market access: ISO 13485 is a recognized global medical device industry standard. Obtaining this certification can enhance our competitiveness, expand international markets, and help gain foreign buyers' trust and cooperation opportunities.

2. Improved quality management level: This certification requires companies to establish and continuously improve their medical device quality management system, including setting quality objectives, document procedures, product control, and risk management. Implementing the ISO 13485 standard can effectively improve our quality management level, reduce product defect rates, and enhance product compliance and safety.

3. Strengthened risk control: The ISO 13485 standard requires companies to establish and continuously improve their risk management system, including risk assessment, control, and monitoring. By implementing this standard, we can better identify and control potential risks during product use, improving product safety and reliability.

4. Enhanced customer satisfaction: ISO 13485 certification emphasizes meeting customer requirements and requires companies to establish and implement effective customer satisfaction evaluation and improvement mechanisms. We can better understand and meet customer expectations and needs