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

REALM – innovative solutions for the creation and evaluation of medical device software

For the direct benefit of patients and healthcare practitioners: the interdisciplinary REALM consortium of 15 European partners set out to develop a collaborative framework through which regulatory authorities, software developers, healthcare professionals and policy offers can jointly create and evaluate innovative medical device software.

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01 Jan 2023 start date
4 Years duration
7.0 Mil € Budget
15 partners from 6 countries

“REALM will contribute to the provision of methodologies, algorithms, tools and reference implementations for the development and adoption of credible and ethically sound medical device software. In addition, we want to remove barriers for the adoption and acceptance of real-world data-driven and artificial intelligence/machine learning-based evaluation, certification, verification and validation of healthcare software. Also important as part of our research is to reduce inequalities in the regulatory field by creating outreach and education channels that are sustainable beyond the project”

Prof. Michel Dumontier, REALM Coordinator

Maastricht University, The Netherlands

“Central to the project will be five case studies, undertaken in The Netherlands, Belgium and Greece, that will validate and improve the REALM platform based on medical device software used to address currently unmet clinical needs, ranging from blood glucose control in patients in intensive care units to testing Pharmacogenomics passports in clinical practice”

Gökhan Ertaylan, Research Lead - Precision Health

VITO, Belgium