Conformity assessment of medical device software and AI

With the emergence of artificial intelligence in medical device software, manufacturers are facing challenges to meet regulatory requirements in an evolving regulatory landscape.

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.