REALM has delivered a portfolio of KERs that strengthen the European framework for evaluating, certifying, and governing AI-driven medical device software (MDSW). The project combines data quality, interoperable infrastructure, certification transparency, regulatory guidance, and capacity building into one coherent approach.
The Multimodal Standard Data Quality Framework (SDQF) provides a regulator-oriented method to assess the quality and robustness of real-world and synthetic data used for MDSW evaluation, supporting reproducible evidence generation. The REALM Data Catalog enables harmonised use of real-world, synthetic, and digital twin data for benchmarking and regulatory-grade validation, while highlighting remaining needs around data governance and licensing.
REALM’s federated infrastructure supports distributed monitoring and evaluation of MDSW performance across multiple nodes, demonstrated across five use cases and designed to support post-market oversight. The blockchain-based certification process embeds certification steps in smart contracts to enable traceable and auditable workflows; further maturation and alignment with standards are needed for broader deployment.
These KERs form the technical basis for a planned spin-off led by VITO and UM, targeting medical AI developers requiring regulatory-grade validation services. An EIC Transition proposal (submitted September 2025) supports further TRL and market validation. In parallel, the REALM Academy translates project methods into training for competent authorities, notified bodies, HTA agencies, and manufacturers, with sustainability options under exploration. Horizon Results Booster activities are supporting exploitation planning and next steps
