Anumana, Inc.

(a) the conformity of the devices is checked, in accordance with the QMS under which the devices are manufactured, before a device is released; (b) the technical documentation and the EU DoC are drafted and kept up-to-date; (c) post-market surveillance are complied with in accordance with Article 10(10); (d) reporting obligations per Articles 87 to 91 are fulfilled; (e) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.