Officers and regulatory representatives of DEMARTA VIRGINIO
BELLETTI FRANCESCO
a) the conformity of the devices is appropriately checked, in accordance with the quality management system ;
b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
c) the post-market surveillance obligations are complied with ;
d) the reporting obligations referred to in Articles 87 to 91 are fulfilled;
e) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.