Mediso Medical Imaging Systems Ltd.

-the conformity of the devices is appropriately checked, in accordance with the QMS under which the devices are manufactured, before it is released -the technical documentation and the EU DoC are drawn up and kept up-to-date -the post-market surveillance obligations are complied with in accordance with Art 10(10) -the reporting obligations referred to in Art 87 to 91 are fulfilled -in the case of investigational devices, the statement ref. to in Section 4.1 of Chapter II of Annex XV is issued