altona Diagnostics GmbH

- the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date - in the case of investigational devices, the statement referred to in Section 4.1 of Annex XIV of the IVDR is issued

- 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 reporting obligations referred to in Article 82 and 86 of the IVDR are fulfilled

- the post-market surveillance obligations are complied with in accordance with Article 10(9) of the IVDR