Officers and regulatory representatives of Biokosmes s.r.l.
TURCONI Andrea
-the conformity of the devices is appropriately checked, in accordance with the QMS under which the devices are manufactured, before a device is released;
-the tech doc and the EU DoC are drawn up and kept up-to-date;
-the PMS obligations are complied with in accordance with Article10(10);
-the reporting obligations referred to in Articles87to91are fulfilled;
-in the case of investigational devices, the statement referred to in Section4.1of Chapter II of Annex XV is issued.