Scarlet

What it does

Company Summary Scarlet is Europe’s only Notified Body specializing in software and AI medical devices. It provides certification under EU and UK regulations, enabling manufacturers to ship continuous updates of software as a medical device (SaMD) and artificial intelligence as a medical device (AIaMD). Scarlet ensures safe access to cutting-edge healthcare technologies. The Problem Regulatory processes for medical software are slow and designed for traditional hardware, not software that updates frequently. Developers struggle to navigate outdated frameworks, face delays in approvals, and waste time on compliance rather than innovation. The Solution Scarlet offers a certification process built specifically for software and AI. It supports continuous compliance, allowing developers to ship frequent updates efficiently. With expert guidance and a scalable framework, Scarlet helps clients enter the EU and UK markets faster and more reliably. Funding In August 2022, Scarlet raised £6M in a Seed round led by Creandum, and in June 2024 raised a $17.5M Series A led by Atomico. Scarlet is an EU Notified Body under Regulation (EU) 2017/745 (EU MDR), a UK Approved Body under UK Medical Devices Regulations 2002, and accredited to issue ISO 13485 certificates.