Dirigeants et représentants réglementaires de CADskills BV
ARTAZCOZ Ane
- the technical documentation and the EU declaration of conformity are drawn up and kept up to date.
- the post-market surveillance obligations are complied with in accordance with MDR Article 10(10).
- the reporting obligations referred to in MDR Articles 87 to 91 are fulfilled.
- in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is
issued.
Masqué
BUNDO Mario
- 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.