Scarlet, a London-based company specialising in the certification of AI and software medical devices, has raised $50 million in a Series B funding round led by Headline. The round included new investor Notion Capital and existing investors Atomico, Creandum, Kindred Capital and Entrepreneurs First.
Co-founded by James Dewar and Jamie Cox, Scarlet provides regulatory certification services for medical device manufacturers developing AI-powered and software-based healthcare products. The founders previously worked on AI medical devices at Babylon Health, where they encountered challenges associated with lengthy regulatory assessment processes.
Scarlet operates a technology-enabled certification platform through which manufacturers submit technical documentation for assessment by qualified reviewers. The platform supports regulatory evaluations and subsequent product updates, helping manufacturers manage certification requirements as their medical software evolves.
The company holds regulatory authorisations as an EU Notified Body and a UK Approved Body under the Medicines and Healthcare products Regulatory Agency (MHRA). In the United States, Scarlet is recognised by the Food and Drug Administration (FDA) as a Third Party Review Organization. Its certification services also cover standards including ISO 13485, ISO/IEC 27001 and ISO/IEC 42001.
Scarlet plans to use the Series B funding to expand its operations in the United States and Asia-Pacific, recruit additional expert AI reviewers and engineers, and broaden its certification offerings.
As part of the financing, Nancy Xiao McLaughlin, Partner at Headline, is joining Scarlet’s board.
