U2: Is this tool a regulated device, and why it matters to me

Whether software is a medical device depends on what the manufacturer intends it for, not on whether it uses AI, and a disclaimer does not undo a medical claim made elsewhere. A mark is a floor, not proof of performance in your setting. In a systematic review of deep learning algorithms for radiological diagnosis, 81 per cent performed worse on external data than on the data they were developed on.

It teaches the legal test for a medical device in Great Britain and the EU, what a UKCA, CE or UKNI mark does and does not tell you, and the governance a manufacturer must operate before and after approval, including your reports. It distinguishes internal validation, external validation, local evaluation and prospective clinical evaluation. It explains why consumer wearables are usually not devices, and closes with a short check to run before you use a tool or recommend one to a patient. It maps to the HEE AI and Digital Healthcare Technologies Capability Framework (2023). Veritant is education, not legal advice.

You receive the Master Teaching Document and slide deck as PDFs, and a narrated video. Reading Veritant (U0), the guide to how the units are built, is included free. An assessed certificate is coming: a 20-question online assessment with a pass mark of 80 per cent. Everyone who has bought the unit will be able to take it free.