Sanway Gene Tech. Inc.

Min Deng is responsible for: 1) establishing and implementing a quality system compliant with EU Regulation IVDR 2017/746; 2) fulfilling post-market surveillance and vigilance obligations, and approving reports, field safety notices, and corrective actions; 3) inspecting device conformity and consistency prior to release in accordance with the quality management system; 4) performing other work required by laws and regulations.

Minmin Liu is responsible for: 1) signing declarations for clinical trial products, stating compliance with general safety and performance requirements except for trial aspects, and that precautionary measures have been taken to protect user health and safety; 2) preparing and maintaining up-to-date technical documentation and EU declarations of conformity; 3) performing other work required by laws and regulations.