Zyris, Inc.

(a) the conformity of the devices is appropriately checked, in accordance with the QMS under which the devices are manufactured, before a device is released; (b) the technical and EU declaration of conformity are drawn up and kept up-to-date; (c) the post-market surveillance obligations are complied with in accordance with Article 10(10); (d) the reporting obligations referred to in Articles 87 to 91 are fulfilled;