REALM Webinar: Transforming Medical Device Software Evaluation with Real World Data

Join us for the free REALM Webinar on real-world data enabled assessment for health regulatory decision-making, where we’ll explore how real-world data (RWD) can help streamline the evaluation of (AI based) medical device software, enhance transparency, and address regulatory challenges.

Notified bodies, regulators, HTA agencies, and developers face increasing hurdles in assessing AI-driven medical software:

• Fragmented real-world data (RWD) hinders comprehensive evaluation
• AI models evolve, requiring new oversight methods
• Regulatory complexity (MDR, IVDR, GDPR) slows approvals
• Transparency & trust remain key concerns

The REALM (Real-world data Enabled Assessment for Health Regulatory Decision-Making) project is developing a solution to address these challenges.

What this webinar covers:

• Standardizing MDSW evaluation – A unified framework for assessment
• Regulatory tools – Bias detection, explainability, and performance validation
• Ensuring transparency – Blockchain & RWD for regulatory decisions
• Real-world applications – What this means for regulatory bodies, HTA agencies & developers

Who should attend:

• Notified bodies, regulators & policymakers: Gain insights into emerging methods for AI model evaluation.
• HTA agencies: Learn how real-world data and AI tools can support reimbursement decisions.
• Software developers: Understand regulatory expectations and best practices for compliance.
• Healthcare professionals & researchers: Explore how these developments impact clinical decision-making.

Don’t miss this opportunity to gain insights into the future of medical device software creation and evaluation!

When: Tuesday, 25 March 2025 15:00 – 16:00 CET

Register now: Microsoft Virtual Events Powered by Teams