REALM aims 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 – for the direct benefit of patients and healthcare practitioners.

The research undertaken by the REALM project is important because it will create a system to test and certify software used in medical devices. The project will provide a way to test the software in real-life situations and standardise the testing process across the European Union. The project will also create a catalogue of health data, clinical images, and other information, and organise it in a way that is easy to use and understand.

The REALM platform is dedicated to providing a comprehensive and easily accessible source of essential medical data for various applications. It adheres to the principles established by DARWIN and aims to simplify the challenging task of locating medical data for innovative solutions and research activities. The platform operates under a multi-procedural framework, offering user-friendly support for developing and implementing applications for post-market utilisation. It utilises cutting-edge practices and technologies for acquiring, storing, processing, and securing medical information, while also providing end-users with limited access medical data to evaluate their algorithms.

Watch The New Animated Clip: Discover How REALM is Revolutionizing Medical Device Software Development

Medical doctors are frequently overwhelmed by data and paperwork, while software developers for medical devices struggle to keep their solutions compliant with ever-evolving regulations. This is largely because regulators lack the necessary means to evaluate advanced medical software effectively.

To address these challenges and foster effective cooperation between professionals in the development stages of medical software, we have initiated the REALM project.

Benefits of the REALM Platform

• For Doctors: Reduced data and paperwork burden, allowing more time for patient care.
• For Developers: Assurance that their solutions comply with the latest regulations.
• For Regulators: Tools to effectively evaluate advanced medical software.
• For Patients: Increased confidence in medical software, leading to better outcomes and a higher quality of care.

This project is funded by the European Union.