Dirigeants et représentants réglementaires de NIKO DENTAL GmbH
WIATREK Werner
According MDR Article 15 §3 (c and d)
c) Post-market surveillance obligations
d) the reporting obligations according to the requirements of the vigilance system
Masqué
ALYOSHIN Anton
MDR Article 15 §3 (a,b and e)
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 technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
e) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.