Formlabs Ohio 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.