VALI AI EUROPE SL

PRRC is responsible for appropriately checking the conformity of the device, in accordance with the QMS, before the release; the TD and the EU DoC are drawn up and kept up-to-date; the PMS obligations are followed according to Art.10(9); the reporting obligations (Art.82-86) are fulfilled; in the case for performance studies intended to be used in interventional clinical performance studies or other involving risks for the subjects, the statement of Sect 4.1,Annex XIV is issued.