Scarlet

Scarlet is a regulatory services firm that operates as Europe's only Notified Body specialised in software and AI medical device certification. It provides certification processes for manufacturers of Software as a Medical Device (SaMD) and AI as a Medical Device (AIaMD), covering regulatory compliance, medical device software certification, and AI medical device assessment.

The company's team is composed of doctors and engineers, and it employs in-house AI tools to support efficient certification workflows. Scarlet's stated aim is to hasten healthcare innovation and make it more accessible through streamlined regulatory pathways.

Scarlet has a presence in the United Kingdom, the Netherlands, and the broader European Union, operating across the healthcare and medical devices sectors. Its work sits at the intersection of clinical expertise, software engineering, and EU regulatory frameworks - an area of growing demand as AI-driven medical products proliferate.