Officers and regulatory representatives of DiaDeep
MARSURA Céline
Devices conformity is appropriately checked in accordance with the QMS before a device is released;
Technical documentation and the EU declaration of conformity are drawn up and kept up to date;
PMS obligations are complied with in accordance with Article 10(9);
Reporting obligations referred to in Articles 82 to 86 are fulfilled;
Where appropriate, Verify that the statement referred to in IVDR Section 4.1 of Annex XIV is issued.