REALM Academy
About
Empowering Regulators, Health Technology Assessors, and Industry in (AI-driven) Medical Device Software Evaluation
REALM Academy is the educational hub of the REALM project, providing targeted training and resources for regulators, notified bodies, competent bodies, HTA agencies, and software developers working in the evaluation, certification, and oversight of Medical Device Software (MDSW).
Through webinars, online training, and workshops, REALM Academy ensures that stakeholders across Europe are equipped with the knowledge, tools, and methodologies to make data-driven, transparent, and standardized decisions in the rapidly evolving landscape of AI-based medical software.
What we offer
REALM Academy provides a structured learning experience in multiple formats:
- 1. Webinars
- A high-level introduction to REALM, its goals, and how it benefits regulatory and industry stakeholders.
- Covers the importance of AI in medical software, key regulatory challenges, and the need for standardized evaluation frameworks.
- Open to regulatory bodies (notified bodies and competent bodies), policymakers, software developers, and healthcare professionals.
Previous session: 27 March 2025
Watch recording - 2. Online training programs
- In-depth structured training for different stakeholder groups:
- HTA Agencies & Competent Bodies: Data-driven decision-making, bias detection, regulatory harmonization
- Notified Bodies: AI in MDSW, certification & compliance under MDR/IVDR
- Software Developers: Best practices for regulatory submission, transparency, and ethical AI.
- Two-part training structure:
- Part 1: Foundational knowledge (current regulations, challenges, introduction to REALM tools).
- Part 2: Practical sessions (hands-on experience with REALM components and evaluation methodologies, once the platform is fully developed).
Upcoming sessions: TBD - In-depth structured training for different stakeholder groups:
- 3. In-Person Workshops
- Interactive, small-group workshops tailored to specific regulatory challenges and practical applications of REALM tools.
- Designed for Notified Bodies, Competent Authorities, HTA Agencies and Industry, these workshops provide:
- Hands-on exploration of REALM’s Standard Data Quality Framework (SDQF) and evaluation methodologies.
- Case studies and practical demonstrations of AI model evaluation, it’s specific challenges and existing methods to deal with them.
- Expert-led discussions on GDPR, MDR/IVDR compliance, and blockchain-enabled certification.
Next workshop: Multi-Stakeholder Insights for Evaluating Medical AI
Date: 5 November 2025
Location: TRACK Brussels
Register here
Stakeholder Impact and Outcomes
Regulators (NBs) and policymakers
They will gain comprehensive insights into the challenges associated with AI model evaluation, including issues related to bias, fairness and transparency. They will explore the existing methodologies that REALM employs to address these challenges effectively. Additionally, they will learn how to leverage the REALM platform to implement standardized evaluation and certification processes across the EU, ensuring consistency and reliability in AI model assessment.
HTA agencies
HTA agencies will learn how to utilize the REALM platform as a powerful tool to gain a transparent and comprehensive overview of the evaluation process behind Medical Device Software (MDSW). This transparency will support informed reimbursement decisions, ensuring that the evaluation process is clear, consistent, and reliable.
Software developers
Software developers will gain a thorough understanding of regulatory expectations and best practices for compliance. They will learn how to navigate the complex landscape of AI regulations and ensure their software meets the highest standards of quality and safety. The REALM platform will provide them with the necessary tools and resources to achieve compliance efficiently and effectively.
Healthcare professionals and researchers
Healthcare professionals and researchers will explore how advancements in AI and the REALM platform impact clinical decision-making. They will gain insights into the integration of AI in clinical workflows, enhancing diagnostic accuracy, treatment planning, and patient outcomes. The platform will provide them with the tools and knowledge to leverage AI effectively in their practice and research.