Autobio Biochemistry Co.,Ltd

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 process complies with the IVDR; the post-market surveillance obligations are complied with in accordance with Article 10(9); 3.the reporting obligations referred to in Articles 82 to 86 are fulfilled;

1.The TD and the EU DOC are drawn up and kept up-to-date. 2.Products' performance evalution involving special risks meets the requirements; For devices conducting clinical performance studies, the statement referred to in Section 4.1 of Annex XIV is issued and signed. 3.Assist in ensuring that the PMS process complies with IVDR; the PMS obligations are complied with in accordance with Article 10(9). 4.the reporting obligations referred to in Articles 82 to 86 are fulfilled with assistance.