Work Packages
The project activities are managed in so-called work packages. REALM is set up around seven such work packages. Different partners, academic and industrial, take the lead on achieving different tasks within a particular work package while ensuring close collaboration with other institutions and across the different work packages.
Explore our Work Packages in detail by clicking the respective WP!
Work Package 1 - Project Management and scientific coordination
Lead: Maastricht University, The Netherlands
Work package 1 provides a clear organisational framework, guidance, and all support mechanisms to enable a smooth project workflow in REALM and to ensure that objectives and milestones will be met on time.
Work Package 2 - Ethical, Legal & Societal Framework
Lead: University of Warsaw, Poland
Work package 2 addresses the challenges of developing and implementing MDSW (Medical Device Software) tools in clinical practice by providing socially responsible ethical-legal standards. This will be achieved through various tasks, including mapping the ethical and societal challenges of using MDSWs, analysing regulatory and legislative frameworks for AI-based medical devices and personal data processing, identifying the use of synthetic data, and engaging MDSW developers with relevant stakeholders. The end goal is to formulate guidelines and standards that will guide the integration of ethical, legal, and stakeholders' considerations in the design process of MDSW.
Work Package 3 - REALM Architecture, & Regulatory Toolbox Methodology
Lead: Metamind Innovations, Greece
Work package 3 establishes the REALM governance and technological architecture, which involves setting up services, system monitoring, and feedback mechanisms. The goal is to create standardised methodologies for evaluating medical and healthcare software. Additionally, a lightweight infrastructure (Blockchain) will be set up to track software evolution. Central to this work packages is to ensure the efficient and effective functioning of the REALM platform and its associated software.
Work Package 4 - Real-World Data & Synthetic Data Repository
Lead: Maastricht University, The Netherlands
Work package 4 establishes a secure and standardised system for managing and sharing data in REALM, while also providing tools for testing and improving medical software.
Work Package 5 - Platform Integration, Real World Testing & Monitoring
Lead: VITO, Belgium
In work package 5, the team works on several objectives related to the evaluation and follow-up of medical devices. This includes the realisation of automated tools to generate synthetic data for the evaluation of MDSW and the creation of tools to select real-world data for evaluation. We will also collect and harmonise heterogeneous data from REALM tools and develop a dashboard for intelligent analytics on MDSW. Additionally, smart tools and metrics will be created to facilitate the cost-effective post-market follow-up of medical devices that comply with existing regulations on Post Market Surveillance and Post Market Clinical Follow up.
Work Package 6 - Pilot Implementation, Demonstration, Validation and certification
Lead: Maastricht University, The Netherlands
The work in work package 6 involves testing the REALM platform at different levels to ensure its correct operation and functionality. This includes unit, system, integration, and end-to-end testing to verify the quality of the integrated platform. The produced REALM artefacts will be delivered for execution and experimental validation at pilot sites. Finally, the team will plan, demonstrate, and evaluate five large-scale use cases to show the potential of the platform and demonstrate its ability to solve real-world problems.
Work Package 7 - Innovation Management: Communication, Dissemination, Networking, Training, Exploitation and Sustainability
Lead: Eurice GmbH, Germany
Work package 7 covers the project’s Innovation Management which follows a multidimensional, integrated and impact-oriented approach. It ensures consistent communication and dissemination, optimal visibility and a wide outreach to relevant stakeholders. Strategic planning and implementation of exploitation through dedicated innovation management safeguards high-quality results that are captured, assessed and used. The team will devise a comprehensive IP management strategy as foundation for further exploitation and sustainability.