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Real-world-data enabled assessment
for health regulatory decision-making

REALM Partners Advance Platform Development at the Technical Workshop

From 27th to 29th November, partners in the REALM project gathered in Brussels for a technical workshop organised by VITO. The three-day meeting focused on partners working together to refine the platform features, testing prototypes, and discussing key technical details to move the project closer to its goals.

The REALM platform aims to provide healthcare professionals, software developers and regulators with a reliable testing environment for software used in medical devices. This environment is supported by real-world data, medical expertise, and up-to-date legal guidelines, establishing a transparent, traceable, and secure framework for testing and evaluation.

Platform Features and Framework

Throughout the workshop, partners made conclusions on several aspects of the REALM platform:

  • Data and Model Quality Frameworks: The team initiated work on comprehensive frameworks to ensure the reliability, transparency, and quality of the platform’s outputs.
  • Version Control and Validation Tools: Partners proposed solutions for better managing version control and validating updates, including improvements to the model card feature.
  • Evaluation Frameworks for Medical Device Software (MDS): Partners developed methods to assess model availability, claims, datasets, and metrics, laying the groundwork for structured evaluations.
  • RIANA Dashboard Prototype: A tool designed to capture use case claims and evaluate medical device software. All the participants tested the dashboard.
  • REALM Academy Development: Stakeholder groups, training levels, and certification processes were defined, creating a roadmap for structured and impactful training initiatives.

Participants used the workshop as an opportunity to test prototypes and work through technical details such as:

  • Testing the registration process and conducting demo sessions to simulate user interactions.
  • Analysing dependencies in the platform’s architecture to ensure smooth connections between components.
  • Addressing design details to improve user experience and reduce errors.

All attendees tested the RIANA dashboard prototype, and feedback will contribute to further improvements. This tool is central to evaluating medical device software and providing structured assessments of claims, datasets, and other key factors.

The workshop served as a key step in refining the REALM platform. With input from all partners, the project is making steady progress toward its goal of delivering a reliable and user-friendly platform for medical device software evaluation.