Officers and regulatory representatives of VIDIA spol. s r.o.
PRIBIŠOVÁ Marieta
to confirm that devices are manufactured in accordance with implemented QMS; Technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; PMS obligations are complied with in accordance with Art.10(9) IVDR; Reporting obligations referred to in Art.82–86 IVDR are fulfilled; In case of interventional study, the statement referred to in Section 4.1 of Annex XIV IVDR is issued.