APT Medical Inc.

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 post-market surveillance obligations are complied with in accordance with Article 10(10) of MDR 2017/745;

a) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; b) the reporting obligations referred to in Articles 87 to 91 of MDR 2017/745 are fulfilled; c) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV of MDR 2017/745 is issued.