Dirigeants et représentants réglementaires de Mediso Ltd.
CSER Daniel
-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