Orantech Inc.

a) 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; (b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; (c) the post-market surveillance obligations are complied; (d) the reporting obligations are fulfilled; (e) in the case of investigational devices, the statement is issued