Chongqing Xishan Science & Technology Co., Ltd.

1.Responsible for organizing the development and maintenance of technical documentation and EU Declaration of Conformity, ensuring their up-to-date status. 2. Issue the declaration specified in Section 4.1 of Chapter II, Annex XV of the MDR if the clinical investigation device and/or performance study device is intended for interventional clinical performance studies or other performance studies involving risks to subjects.

Conduct appropriate conformity checks on the device before product release in accordance with the quality management system.

1.Responsible for conducting post-market surveillance activities in accordance with the requirements of the MDR. 2.Responsible for reporting to the competent authorities in accordance with the requirements set out in Articles 87 to 91 of the MDR.