SEJONG 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, befor 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 obligation are complied with in accordance with Article 10(10);(d)the reporting obligations referred to in article 87 to 91 are fulfilled;