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ISO 9001:2015 Quality Management System
UDEM Adriatic d.o.o. is accredited by the Croatian Accreditation Agency for the certification of quality management systems according to ISO 9001:2015.
Our accreditation scope is available at the following link.
ISO 13485:2016 Medical Devices Quality Management System Certification
UDEM Adriatic d.o.o. is accredited by the Croatian Accreditation Agency for the certification of quality management systems for medical devices according to ISO 13485:2016.
Our accreditation scope is available at the following link.
Regulation (EU) 2017/745 on Medical Devices — MDR
UDEM Adriatic d.o.o. is a designated Notified Body under Regulation (EU) 2017/745 on medical devices (MDR) for conformity assessment procedures according to Annex IX, Chapters I and III; Annex IX, Chapter II; and Annex XI, Part A.
UDEM Adriatic d.o.o. is listed in the European Commission’s NANDO database with Notified Body identification number 2696.