London-based certification firm Scarlet has secured $50 million in a Series B funding round. The investment was led by Headline, with participation from Notion Capital, Atomico, Creandum, Kindred Capital, and Entrepreneurs First. Following the deal, Nancy Xiao Mclaughlin from Headline has joined the company's board of directors.
Founded in 2021 by James Dewar and Jamie Cox, Scarlet specializes in the certification of AI and software-based medical devices. The company is a government-designated body recognized by regulators in the EU, the UK, and the US, where it acts as a Third Party Review Organisation. It is currently the only organization among approximately 52 EU-designated bodies focused exclusively on AI and software.
Scarlet operates an AI-enabled platform where clients submit technical documentation for regulatory assessment. The company provides certification for both medical device products and the development processes behind them. Its client base includes organizations such as Flo Health, DeepHealth, NHS England, Skin Analytics, Heidi Health, and Tandem.
The company plans to utilize the new capital to scale its operations in the United States and the Asia-Pacific region. Additionally, the funding will support the recruitment of further AI reviewers and engineers, as well as the expansion of the firm's existing certification service offerings.
