Officers and regulatory representatives of Icare Finland Oy
HYVÖNEN Hannes
-the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date
-the reporting obligations referred to in Articles 87 to 91
-in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV
Hidden
HAULISTO Rami
-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.
-the post-market surveillance obligations are complied with in accordance with Article 10(10)