REALM – innovative solutions for the creation and evaluation of AI medical device software.

This poster presents the REALM project, a European initiative developing a transparent and robust framework for the certification and evaluation of AI based Medical Device Software. REALM leverages the OMOP Common Data Model and its extensions to harmonize diverse healthcare data and generate standardized test datasets for regulatory assessment.

By integrating real world data, synthetic data generation, and digital human twin technologies, the project establishes a regulatory sandbox environment that enables rigorous, reproducible evaluation of AI models in healthcare. Funded by the European Union under Grant Agreement No. 101095435, REALM aims to strengthen trust and reliability in AI driven medical software across Europe.