Interacoustics A/S

Ensuring that the reporting obligations referred to in Articles 87 to 91 of (EU) 2017/745 are fulfilled.

Ensuring that 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, and for ensuring the post-market surveillance obligations are complied with in accordance with Article 10(10) of the (EU) 2017/745.

Ensuring that the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date, and that, in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV of the (EU) 2017/745 is issued.