Imagine trying to get a new app approved by health officials, but every country has different rules and no clear checklist. This project builds a shared digital workspace where developers and regulators can test software together using actual patient data. It's like a flight simulator for medical apps to ensure they are safe before they hit the market.
Medical software developers face inconsistent regulatory guidelines and slow certification processes. This creates a bottleneck that delays the deployment of life-saving digital health tools.
A regulatory sandbox consisting of Model Cards for documentation, a federated cloud data catalog, a Regulatory Toolbox, a Living Lab, and a post-marketing surveillance module.
If you are a software developer dealing with slow and unpredictable certification cycles — this project developed a Regulatory Toolbox and Model Cards that standardize documentation and testing. This allows you to prove your software's safety more efficiently using real-world data.
If you are a hospital operator dealing with the risk of deploying unproven digital tools — this project developed a Living Lab and post-marketing surveillance module. This ensures the software you buy maintains high quality standards during actual clinical use.
If you are a consultant dealing with fragmented EU regulations for health apps — this project developed a federated cloud-based data resources catalog. This provides a standardized set of data and tools to help your clients navigate the certification process faster.
Based on available project data, there is no specific pricing model or cost mentioned for the end-user; the project was funded by a EUR 6,659,650 EU contribution.
Yes, the project is designed as a federated cloud-based architecture and is being piloted across 3 countries (Netherlands, Belgium, and Greece) to ensure scalability.
Based on available project data, specific IP and licensing terms are not detailed, though it involves a consortium of 16 partners including 7 SMEs.
The project maps and analyzes regulations from EU and national bodies to create a standardized Regulatory Toolbox for testing and monitoring software.
The project period runs from 2023-01-01 to 2026-12-31.
The consortium is highly balanced for commercialization, featuring a 44% industry ratio with 7 SMEs and 7 industry partners. This mix of 16 partners across 7 countries suggests a strong bridge between academic research (14 university/research entities) and practical market application, specifically targeting the medical software niche.
Contact Universiteit Maastricht regarding the Regulatory Toolbox and Model Cards.
Contact us to find a partner in the REALM consortium for medical software certification.
