Scarlet, a London-based certification body specializing in artificial intelligence and software medical devices, has closed a $50 million Series B funding round led by Headline. The investment sees participation from Notion Capital, Atomico, Creandum, Kindred Capital, and Entrepreneurs First.
Founded in 2021, Scarlet provides certification services tailored specifically for AI-native medical devices, addressing a gap in the regulatory landscape as these technologies become increasingly prevalent in healthcare. The company currently holds designation as the only EU-notified body focused exclusively on AI-enabled medical device certification, positioning it at the intersection of Europe’s stringent regulatory requirements and the rapid advancement of medical AI.
Scaling operations across key markets
The capital injection will fund Scarlet’s expansion into the United States and Asia-Pacific regions, reflecting the global demand for specialized certification expertise. Beyond geographic growth, the company plans to strengthen its internal capabilities by recruiting additional expert AI reviewers and engineers. These additions will enable Scarlet to broaden its certification offerings and handle increased volumes as more companies seek to bring AI-powered medical devices to market.
“We’re building AI-native certification to help our customers bring cutting-edge innovation to patients around the world,” said James Dewar, Co-founder and CEO of Scarlet. The statement underscores the company’s mission to streamline pathways for developers while maintaining the rigorous safety and efficacy standards expected in medical technology.
Addressing regulatory bottlenecks
The timing of this funding reflects broader industry dynamics. Regulatory frameworks governing AI and software in medical devices remain relatively nascent in many jurisdictions, with organizations struggling to balance innovation velocity against patient safety requirements. Scarlet’s expertise in navigating these complexities has positioned the company as a critical infrastructure player within the medtech ecosystem.
The company’s focus on AI-native certification particularly distinguishes it from traditional notified bodies that apply conventional assessment methodologies to newer technologies. As machine learning models and algorithmic decision-making become embedded in clinical workflows, specialized expertise in evaluating these systems has become increasingly valuable.
European healthtech context
Scarlet’s expansion plans align with a broader trend of European healthtech companies scaling internationally while maintaining their regulatory expertise at home. The funding round demonstrates continued investor confidence in European medtech infrastructure, despite competitive pressures from better-capitalized US and Asian rivals. With major institutional backing from established European venture firms, Scarlet represents the type of deep-tech enterprise infrastructure that venture capital has increasingly prioritized within the continent’s startup ecosystem.
The company’s trajectory also reflects growing recognition that regulatory compliance and innovation need not be at odds. As healthcare systems worldwide accelerate their adoption of AI technologies, specialized certification bodies may become as critical to the ecosystem as the device developers themselves.