Scarlet has raised $50.0M in Series B funding to expand its work as a certification body for AI-powered medical devices. The round was led by Headline, with participation from Notion Capital, Atomico, Creandum, Kindred Capital, and Entrepreneurs First.
The London-based company performs conformity assessments against EU MDR and UK MDR regulations and is recognized by the FDA as a Third Party Review Organisation. It also issues ISO 13485, ISO/IEC 27001, and ISO/IEC 42001 certificates, and supports international certification under the Medical Device Single Audit Program. Scarlet's pitch is that AI medical devices need a certifier built for them specifically - one that can handle the iterative updates common to AI products while keeping patients safe and regulators satisfied.
















