Scarlet

Scarlet is a Notified Body based in Europe, and the only one on the continent specialised in the certification of software and AI medical devices. It works with manufacturers of Software as a Medical Device (SaMD) and AI as a Medical Device (AIaMD), providing a certification process designed specifically for those products rather than adapted from general medical device procedures.

The company operates across Europe, including the UK, the Netherlands and the wider EU. Its assessment work is carried out by a team of doctors and engineers, and it uses in-house AI tools to support the certification process. The stated aim is to enable manufacturers to bring safe and effective software and AI medical devices to market more quickly, and thereby to increase access to healthcare.

Technical domains covered include SaMD, AIaMD, medical device regulation and certification, and the development of its own AI tooling. The market position claimed is that of Europe's only Notified Body focused on this segment.