Officers and regulatory representatives of ICURA ApS
JESSEN Lars
(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 (d) the reporting obligations (e) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.