Galena Pharma Oy

(b) the technical documentation and the EU DoC are drawn up and kept up-to-date;(c) the PMS obligations are complied ref. Art. 10(10);(d) the reporting obligations ref. to in Art. 87 to 91 are fulfilled; ref. to vigilance reporting.(e) in the case of investigational devices, the statement ref. to Annex XV. Deputy:(a) the conformity of the devices is appr. checked, in accordance with the QMS under which the devices are manufactured, before releasing.

(a) the conformity of the devices is appr. checked, in accordance with the QMS under which the devices are manufactured, before releasing. Deputy: (b) the technical documentation and the EU DoC are drawn up and kept up-to-date;(c) the PMS obligations are complied ref. Art. 10(10);(d) the reporting obligations ref. to in Art. 87 to 91 are fulfilled; ref. to vigilance reporting.(e) in the case of investigational devices, the statement ref. to Annex XV.