Jeisys Medical Inc.

‧ The technical documentation and the EU declaration of conformity are drawn up and kept up-to-date. ‧ In the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.

‧ 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. ‧ The post-market surveillance obligations are complied with in accordance with Article 10 of the EU MDR 2017/745. ‧ The reporting obligations referred to in Articles 87 to 91 of the EU MDR 2017/745 are fulfilled.