ISO 9001:2015 Quality Management System

UDEM Adriatic d.o.o. is accredited certification company related to ISO 9001:2015 and you can find our certification scope on this link.

ISO 13485:2016 Medical Devices Quality Management System

UDEM Adriatic d.o.o. is accredited certification company related to ISO 13485:2016 and you can find our certification scope on this link.

2017/745/EU Medical Devices Regulation

UDEM Adriatic d.o.o. is a Notified Body related 2017/745/EU Medical Devices Regulations at Annex IX(I), Annex IX(II) and Annex XI(A). We are designated at NANDO - Number 2696. 

UDEM Adriatic MDR Scope