Tenex Health, Inc.

(a) the conformity of the devices is appropriately checked, in accordance with the QMS under which the devices are manufactured; (b) the technical documentation and EU declaration of conformity are drawn up and kept up-to-date; (c) the PMS obligations are complied with; (d) the reporting obligations are fulfilled; (e) for investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV of 2017/745 is issued.