Dirigeants et représentants réglementaires de Inion Oy
VENTO Saara
Ensuring that:
(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;
Masqué
MARTTINEN Kati
- the technical documentation and the EU DoC;
- the post-market surveillance obligations;
- 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 is issued.