Dirigeants et représentants réglementaires de This GmbH
VORTANZ Patrick
(a) the conformity of the devices with the QMS under which the devices are manufactured, before a device is released;
(b) the technical documentation and the EU DoC are drawn up and kept up-to-date;
(c) the PMS obligations are complied with in accordance with Article 10(10);
(d) the reporting obligations referred to in Articles 87 to 91 are fulfilled; (e) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.