Yushin Medical Co., Ltd.

(a) 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; (b)the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; (c)the post-market surveillance obligations are complied with in accordance with Article 10(10); (d)the reporting obligations referred to in Articles 87 to 91 are fulfilled;