KaiXin Chen

I am familiar with medical device quality management system standards such as ISO 13485 and can establish and maintain a quality management system that meets the requirements of the standards. I have extensive experience in quality audits and verification, and can conduct internal and external audits, as well as conduct quality assessment and management of suppliers. I am able to effectively manage the risks of medical device products and develop risk management plans and control measures to ensure that products meet safety and performance requirements. I understand medical device regulatory requirements and can ensure product registration, certification, and reporting comply with regulatory requirements. Through my efforts and expertise, I am committed to ensuring the quality and safety of medical device products, providing patients with reliable medical solutions, and contributing to the company's development and customer trust.