Genolution Inc.

1.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. 2.the technical documentation and the EU declaration of conformity are drawn up and kept up to date. 3. the post-market surveillance obligations are complied with in accordance with Article 10(10). 4. the reporting obligations referred to in Articles 87 to 91 are fulfilled.