Scarlet
AI-native certification body for software and AI medical devices
About
Scarlet is a London-based, government-designated certification body (EU MDR Notified Body 3022) that specialises in software and AI medical devices. Founded in 2021 by James Dewar (CEO) and Jamie Cox after building AI medical devices at Babylon Health, it holds designations from the EU and the UK's MHRA and is recognised by the US FDA as a Third Party Review Organisation. Manufacturers upload technical documentation to its AI-enabled platform, qualified reviewers assess it against regulations and issue certification decisions, and a subscription covers ongoing surveillance, annual audits and product changes. In October 2026 it announced a $50M Series B led by Headline, with Notion Capital, Atomico, Creandum, Kindred Capital and Entrepreneurs First, to expand into the US and Asia-Pacific.
- Website
- scarlet.cc
- Stage
- series-b+
- Location
- London, UK
- Added via
- web
- Ownership
- unclaimed