Medea

Medea™ automates the most time-consuming phases of Clinical Evaluation Report production — helping Medical Device compliance teams and CROs meet EU MDR 2017/745 requirements faster, more accurately, and with permanent audit readiness.

The Problem Medea™ SolvesUnder EU MDR 2017/745, every medical device placed on the European market must be supported by a rigorous Clinical Evaluation Report (CER). Each CER requires an average of 120 hours of work — with up to 35% of that time consumed by systematic literature review, evidence appraisal, and risk-benefit analysis.This work is critical. It is also largely manual, highly repetitive, and disproportionately expensive relative to the value it generates. 


Notified Bodies are rejecting an increasing share of submissions for incomplete or poorly structured documentation.