We work at the forefront of new technology and regulatory science to support the assessment of innovative medical technologies including AI-enabled medical devices and software.
Healthcare systems are increasingly reliant on digital platforms, artificial intelligence, and connected and software-enabled physical devices to facilitate care and support healthcare providers. As the complexity and capabilities of these systems expands, increased attention is needed to ensure they meet relevant safety and performance requirements.
The EU regulations for medical devices (MDR 2017/745), in vitro diagnostics (IVDR 2017/746), and high-risk AI (upcoming EU AI act) each place new requirements on stakeholders across the medical and regulatory space. We work to develop and improve the digital infrastructure used to assess innovative medical devices by developing modern digital compliance tools.
Through research projects, we explore the assurance, data quality, and risk management impact of AI in both clinical and non-clinical settings and provide clarity on current and upcoming regulatory challenges by publishing white papers.
AI Medical Device Software under the MDR
Read our recommendations regarding automation bias and performance conformity assessment of AI medical device software in a changing regulatory landscape.
Clinical decision support software
Regulatory landscape in Europe from May 26th 2020
Towards trustworthy industrial AI systems
Read our position paper giving perspectives on what needs to be considered in developing verification processes and the assurance of AI systems in industrial contexts.