ST. Shine Optical Co.,Ltd.

1. The conformity of the devices is appropriately checked, in accordance with the quality management system before a device is released; 2. The EU technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; 3. The EU post-market surveillance obligations; 4. The EU reporting obligations; 5. In the case of EU investigational devices, the statement is issued in accordance with the EU regulations.