New REALM video presents an approach to evaluating AI-based medical device software

Artificial intelligence is transforming healthcare rapidly, creating new opportunities for diagnosis, treatment and care. At the same time, regulatory and assessment processes need to keep pace with the development of AI-enabled medical device software.

The EU-funded REALM project has released a new animated video presenting its approach to the safe, transparent and evidence-based evaluation of AI-based medical device software throughout its lifecycle.

The video is aimed primarily at notified bodies involved in assessing the conformity and performance of medical device software. It also provides relevant information for developers, regulators and health technology assessment bodies.

The REALM platform combines federated real-world data sources, synthetic data, data quality assessment, Model Cards, regulatory evidence packages, pre-market sandbox environments, post-market monitoring and blockchain technology.

Together, these components support reliable evidence generation, transparent decision-making and the continued assessment of AI models after their deployment.

REALM’s approach is guided by one central objective: enhancing patient safety while supporting the responsible development and evaluation of innovative medical technologies.

Watch the video on YouTube: https://youtu.be/1RTTVii438Q?si=D3E8xh-4Mkowap_n