Dirigeants et représentants réglementaires de This AG
VORTANZ Patrick
a) conformity of devices with QMS under which the devices are manufactured, b) technical documentation and the EU DoC are drawn up and kept up-to-date, c) PMS obligations in accordance with Art 10(10), d) reporting obligations referred to in Art 87 to 91 are fulfilled, e) in case of investigational devices the statement referred to in sec 4.1 of chapter II of Annex XV is issued