MDT Int'l SA

Art.15(3): a) the conformity of the devices is appropriately checked, in accordance with the QMS under which the devices are manufactured, before a device is released; b) the Technical Files and the EU DoC are drawn up and kept up-to-date; c) the PMS obligations are complied with in accordance with Art.10(10); d) the reporting obligations referred to in Art. 87 to 91 are fulfilled; e) in the case of investigational devices, the statement referred to in Section 4.1 of Chap.II of Ann.XV is issued.