Dirigeants et représentants réglementaires de Nivalit Sp. z o.o.
KOMNATA Wojciech
Checking the compliance of devices with the quality management system in which the devices are manufactured, before a device is released;
Preparation and ongoing updating of technical documentation and EU declaration of conformity;
Compliance with post-market surveillance obligations in accordance with Art. 10 (10 ) MDR;
Fulfilling the reporting obligations referred to in Art. 87-91 MDR;
In the case of test devices, issue of the statement referred to in Section 4.1 of Chapter II of Annex XV MDR.