Artificial Intelligence (AI) and Machine Learning (ML) in medical devices are reshaping disease prevention, diagnosis, and management. The technologies enable more timely and accurate detection, personalised treatment decisions, and continuous, real-time monitoring – which can significantly improve outcomes and efficiency across healthcare systems.
But it is a fast-paced field with a complex regulatory landscape – and a subject matter utterly shrouded in information.
To distil the signal from the noise, our Head of eHealth Dr. Dirk Hüber and Senior Consultant Nik Bartlett have teamed up to produce a comprehensive overview of the current regulatory landscape in the EU and US with respect to AI and ML in medical devices.
Following on from our October 2024 article on this topic, in the whitepaper below, Dirk and Nik take a look at the evolving expectations of the regulatory bodies in the EU and US FDA regarding:
- Medical devices that are an AI system or include an AI component – also called Medical Device Artificial Intelligence (MDAI)
- Medical devices that include ML – also called Machine Learning-enabled Medical Devices (MLMDs)
Whilst the focus of this whitepaper is on the regulation of MDAIs (including MLMDs), some broader topics relevant to the medical device industry such as tools containing AI, or relevant for AI such as sustainability and ethics, are also included.
Download the free whitepaper below, and should you have an MDAI challenge, feel free to get in touch with our experts.
