Orthoget Sp. z o.o.

-checking the conformity of the devices, in accordance with the quality management system under which the devices are manufactured, before a device is released; -assuring that the technical documentation and the EU declaration of conformity up-to-date; -the reporting obligations referred to in Articles 87 to 91 are fulfilled; -in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.