Private Enterprise "Toros-Group"

(a) the conformity of the devices is appropriately checked, in accordance with the quality management system; (b) the technical documentation and the EU declaration of conformity are drawn up and updated; (c) the PMS obligations are complied with in accordance with Article 10(10); (d) the reporting obligations referred to in Articles 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.