Scarlet
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 Developers struggle to navigate outdated frameworks, face delays in approvals, and waste time on compliance rather than innovation.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, with participation from Kindred Capital. 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.
Founders
James Dewar
CEO
James graduated from Goldsmiths University with a First Class degree in Computer Science. He went on to complete a Master’s degree in Machine Learning at Imperial College London, before joining Babylon Health as a Senior Data Scientist.
Jamie Cox
CTO
Jamie originally studied medicine before becoming a software engineer. He holds a Bachelor’s degree in Surgery from the University of Bristol. He worked on groundbreaking AI at Babylon Health before launching his own startup.