OPTICUS DOO BELGRADE

ensuring that: (a) the conformity of the devices is appropriately checked, in accordance with the QMS, before a device is released (b) the technical documentation and the declaration of conformity are drawn up and kept up-to-date (c) the PMS obligations are complied with in accordance with Art. 10(10) (d) the reporting obligations referred to in Art. 87 to 91 are fulfilled (e) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued