BSN Medical Inc.

Responsible for ensuring that the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date (art. 15 para. 3 (b)) and the vigilance reporting obligations are fulfilled (d)

Responsible for ensuring that 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 (art. 15 para. 3 (a)), the post-market surveillance obligations are complied with (c) and in the case of investigational devices a statement of device conformity is issued (e)