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The aim of the REALM project, funded by the European Commission under the HORIZONT-HLTH-2022 programme, is to create a multi-stakeholder ecosystem for the co-development and evaluation of medical device software.

The interdisciplinary consortium of the European research project REALM, composed of 13 European partners and two associated partners, will develop a collaborative framework through which regulatory authorities, software developers, healthcare professionals and policy offers can jointly create and evaluate innovative medical device software – for the direct benefit of patients and healthcare practitioners.

The project formally started on January 1st, 2023, and work was inaugurated on January 19th-20th, 2023 at the first consortium meeting in Mastricht, Netherlands.

Participants in the REALM (Real-world-data Enabled Asassessment for heaLth regulatory decision-M aking) research project consortium, which includes academic, clinical and technology partner institutions from Belgium, Germany, Greece, Poland, the Netherlands, as well as associated partners from the UK, will develop an innovative and inclusive platform that leads to a transparent ecosystem for software assessment and certification in healthcare, in which developers as well as regulators and health technology assessment bodies have access to a standardised set of technology and data stacks.

For more information, visit the project website.