Shenzhen Core Medical Technology Co., Ltd.

1.the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; 2.In the case of investigation devices,the statement referred to in MDR Section 4.1 of Chapter II of Annex XV is issued;

1.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; 2.The post-market surveillance obligations are complied with in accordance with MDR Article 10(10); 3. The reporting obligations referred to in MDR Articles 87 to 91 are fulfilled;