Upcoming REALM Webinar: Transforming Medical Device Software Evaluation with Real-World Data
As artificial intelligence (AI) and machine learning (ML) revolutionize medical device software (MDSW), notified bodies, regulatory bodies, health technology assessment (HTA) agencies, and developers face increasing challenges in ensuring transparency, trust, and compliance.
Are our evaluation processes keeping up with this rapid evolution?
The REALM (Real-world data Enabled Assessment for Health Regulatory Decision-Making) project invites you to a free, expert-led webinar on 25th March 2025, exploring how real-world data (RWD) can streamline the evaluation of AI-based medical device software, enhance regulatory decision-making, and tackle key challenges in compliance.
Why Attend?
Medical AI solutions hold great promise, but regulatory hurdles persist:
- Fragmented RWD makes comprehensive evaluation difficult
- AI models evolve constantly, demanding new oversight methods
- Regulatory frameworks (MDR, IVDR, GDPR) require streamlined compliance strategies
- Transparency & trust remain critical concerns
To address these challenges, the REALM project is developing a unified framework for AI-based medical device software assessment, incorporating RWD, bias detection tools, blockchain solutions, and regulatory insights.
What This Webinar Covers:
- Standardizing MDSW evaluation – A unified approach to assessing AI-driven medical software
- Regulatory tools – Bias detection, explainability, and performance validation
- Ensuring transparency – How blockchain & RWD can enhance regulatory decisions
- Real-world applications – What this means for regulators, HTA agencies & developers
Who Should Attend?
- Notified bodies, regulators & policymakers – Gain insights into AI model evaluation
- HTA agencies – Learn how RWD can support reimbursement decisions
- Software developers – Understand compliance requirements and best practices
- Healthcare professionals & researchers – Explore how these advancements impact clinical decision-making
Who are the speakers?
- Dr Gökhan Ertaylan – REALM co-coordinator and Research lead at VITO
- Dr Chang Sun - Assistant Professor at the Institute of Data Science, Faculty of Science and Engineering, Maastricht University
- Janaki Raman Rangarajan – Scientific Officer at VPHi
- Dr Rebekka Van Hoof - Postdoc at VITO
How to Join?
Don’t miss this opportunity to gain expert insights into the future of AI-driven medical device software evaluation! Register & join the webinar here.