Officers and regulatory representatives of BRITENET MED
MAKOWSKI Karol
-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 technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
-the post-market surveillance obligations are complied;
-the reporting obligations are fulfilled;
-in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV MDR is issued