Endologix LLC

The Alto System: 1. The Technical Documentation and the EU Declaration of Conformity are drawn up and kept up to date. 2. In the case of investigational devices, the statement referred to in Section 41 of Chapter II of Annex XV is issued

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 post-market surveillance obligations are complied with in accordance with Article 10(1) of the Medical Device Regulation 2017/745. 3. The reporting obligations referred to in Articles 87 to 91 are fulfilled.