Zybio Inc.

1.Comply with the required post-market surveillance obligations. 2.ensure continuous maintenance of the post-market surveillance system. 3.in case of vigilance get in contact and communicate with competent authorities on behalf of the organization. 4.ensure compilation of necessary reports resulting from post-market surveillance obligations. 5.The PRRC reports on a regular basis to management.

1.The conformity of the devices is appropriately checked,in accordance with the quality management system under which the medical devices are manufactured, before a device is released 2.The technical documentation and the EU declaration of conformity are draw up and kept up-to-date; 3.The PRRC reports on a regular basis to management.

1.The conformity of the devices is appropriately checked,in accordance with the quality management system under which the medical devices are manufactured,before a device is released 2. The technical documentation and the EU declaration of conformity are draw up and kept up-to-date; 3. Perform the obligation of reporting to the competent authorities; 4. Comply with the required post-market surveillance obligations