Officers and regulatory representatives of Vitestro B.V.
GIESEN Luuk
(a) the conformity of the devices is checked, in accordance with the QMS under which the device is manufactured, before a device is released;
(b) the TD 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) MDR;
(d) the reporting obligations referred to in Articles 87 to 91 MDR are fulfilled;
(e) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV MDR is issued.