Officers and regulatory representatives of OstomyCure AS
AMIRI Ladan
The conformity of the devices is appropriately checked, in accordance with the QMS under which the devices are manufactured before a device is released. The TD and the EU DoC are drawn up and kept up to date. Not responsible for signing the declaration of conformity. The PMS obligations are complied with in accordance with MDR. The Vigilance reporting. In the case of investigational devices, the statement referred to in MDR Section 4.1 of Chapter II of Annex XV is issued.