If you are a device manufacturer dealing with complex security requirements for the MDR — this project developed automated cybersecurity assurance tools that reduce the time spent on manual safety verification.
Automated Cybersecurity Assurance for Connected Medical Devices
Imagine your medical devices are like smartphones that need constant updates to stay safe from hackers. Instead of manually checking every single part, this project creates a smart system that automatically spots weak points and fixes them. It acts like an automated security guard that ensures life-saving equipment stays online and safe.
What needed solving
Medical device manufacturers face long, complex paths to market due to strict security and safety regulations. Current security tools are often ineffective against new types of vulnerabilities in connected healthcare architectures.
What was built
A set of automated cybersecurity assurance tools and management solutions. These include models for device architectures and a system to capture and act on security threats.
Who needs this
Who can put this to work
If you are a provider dealing with diverse connected device architectures — this project developed a system to manage security threats across different components, improving your overall cyberdefence.
If you are an auditor dealing with the difficulty of verifying device safety at scale — this project developed verifiable secure system engineering management solutions that automate the assurance process.
Quick answers
What is the cost or price of the solution?
Based on available project data, the EU contribution is EUR 4,792,365, but the specific commercial price for the resulting tools is not listed.
Can this be deployed at an industrial scale?
Yes, the project specifically aims to provide scalable and verifiable management solutions to handle the diverse commercial EU medical device market.
How is the IP and licensing handled?
Based on available project data, specific licensing terms are not provided, though the solution is co-developed with industrial user partners.
Does this help with medical regulations?
Yes, the project addresses regulatory ramifications and the MDR to help devices overcome market barriers related to security requirements.
How does this integrate with existing systems?
The project focuses on interoperability and the interdependence of several IoMT subsystems to ensure a harmonious evolution of secure devices.
Who built it
The consortium is heavily industry-weighted with a 46% industry ratio, comprising 6 companies and 5 SMEs across 8 countries. This strong commercial presence, combined with 4 universities and 1 research center, suggests the output is designed for immediate market application rather than purely theoretical research.
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