New REALM video explores the evaluation of AI-based medical device software

As artificial intelligence (AI) becomes increasingly integrated into healthcare, ensuring the safety, reliability and effectiveness of AI-based medical device software presents new challenges for developers and regulatory authorities. How can these technologies be evaluated using trustworthy data and reliable evidence?

A new video from the REALM project brings together perspectives from six project partners to explore these challenges and explain how REALM is working to support the evaluation of AI-based medical device software.

Through interviews with researchers, technical experts and developers, the video highlights the importance of high-quality health data, independent evaluation and transparent evidence generation in supporting regulatory decision-making.

It also introduces some of REALM's key approaches, including the Standard Data Quality Framework, synthetic data and the evaluation of AI models using real-world health data. Partners share insights into how these approaches can support developers in assessing their solutions and help competent authorities, notified bodies and other regulatory stakeholders access more reliable evidence.

Recorded during the REALM consortium meeting in Split, Croatia, the video offers an overview of the project's work towards a more transparent, efficient and trustworthy evaluation process for AI-based medical device software.

Watch the video to learn how REALM aims to support regulatory decision-making and contribute to bringing safe and effective AI innovations into healthcare.

Watch the video on YouTube: https://youtu.be/4v2iQV7IZHI?si=ccy-VMBhIZOkQEgb