Dirigeants et représentants réglementaires de Septidin
KOSIMOV Yorkin
a) the conformity of the devices is appr. checked in accordance with the QMS under which the devices are manufactured, before releasing. b) the technical documentation and the EU DoC are drawn and kept up-to-date. c) the PMS obligations are complied with ref. Art. 10(10). d) the reporting obligations for vigilance reporting and analysing of the data (MDR Art. 87 to 91) are fulfilled. e) in the case of investigational devices, the statement referred to in Annex XV chapter II sect. 4.1 is issued.