GRI Medical & Electronic Technology Co., Ltd.

a) Sign-off authority for changes to procedures, processes, designs, etc. b) Authority to act on behalf of top management during the audit; c) Responsibility for managing quality audit functions; d) The technical documentation and the EU declaration of conformity are drawn up and kept up-to-date；

a) Responsibility for contributing to corrective and preventive action activities, complaint handling and the handling of nonconforming product, etc. b) The conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released.

a) Establishing, implementing and maintaining a QMS and reporting to top management; b) Ensuring the promotion of awareness of applicable regulatory and QMS requirements throughout the organization； c) Authority to place products or processes on hold; d) Contact with external cooperators on QMS; e) The PMS obligations are complied with in accordance； f) Reporting serious incidents and field safety corrective actions, trend reporting, analysis of vigilance data.