Yung Sheng Optical Co., Ltd.

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

1.the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; 2.the post-market surveillance obligations are complied with in accordance with Article 10(10); 3.the reporting obligations referred to in Articles 87 to 91 are fulfilled; 4.in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.