REALM: Real-world-data enabled assessment for health regulatory decision-making

Medical Device Software is advancing quickly, but the current evaluation processes are outdated, making it difficult to get approval and implement these innovations. The REALM project is creating a collaborative platform to evaluate and certify Medical Device Software in the European Union. This platform brings together regulatory bodies, developers, and healthcare professionals to address the current needs of the Medical Device Software industry. REALM provides comprehensive testing, benchmarking data, and standardisation by collaborating across multiple cloud infrastructures. It integrates real-world and synthetic health data to ensure AI-driven medical solutions are safer and more effective.