NanoRepro AG

a) ensuring that the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; b) ensuring that the post-market surveillance obligations are complied with in accordance with Article 10(9) of IVDR.

a) 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; b) ensuring that the reporting obligations referred to in Articles 82 to 86 of IVDR are fulfilled.