Medical technology certification company Scarlet has raised $50m in Series B funding led by Headline Growth, with Notion Capital joining the investment alongside existing backers, as demand grows for faster assessment of regulated software and AI-powered medical devices.
The London-founded business operates as a certification and conformity-assessment organisation, examining whether products meet regulatory requirements before they can enter or remain in specified markets. The funding announcement reflects investor interest in improving an area of healthcare technology that is less visible than product development but critical to commercialisation.
Medical device makers may spend substantial time documenting product performance, clinical evidence, risk controls and compliance with applicable standards. Software introduces an additional difficulty because products can change frequently, particularly when AI models are updated. A system that can be improved rapidly in development may still require careful regulatory review before a modified version is supplied to customers.
Scarlet’s founders, James Dewar and Jamie Cox, encountered these challenges while working on medical software at Babylon Health. They established the business to combine regulatory expertise with AI-enabled workflows and more continuous information handling. Scarlet says its model can help reduce administrative delays without removing the need for evidence or human oversight.
Headline, the lead investor, has presented the round as a bet on certification infrastructure suited to software development. Notion Capital also participated, alongside investors including Atomico, Creandum and Kindred. The financing follows previous investment in the business and is intended to support expansion rather than a completed purchase of another company.
The company is authorised for assessment activities in the UK and European Union and holds relevant recognition in the United States. These distinctions matter because a certification body’s authority depends on specific product classes, regulatory programmes and jurisdictions. Recognition in one area is not an automatic licence to approve every kind of medical technology.
Regulation can create a substantial barrier to entry for health technology companies. Products developed for hospitals and clinicians must provide confidence not only that they function technically, but also that patients can be protected, failures identified and performance monitored after deployment. Assessment bodies are part of the wider infrastructure that allows innovation to reach customers under a credible safety framework.
Software-based medical devices can change rapidly as developers introduce new versions and AI capabilities. Software businesses may want to release improvements at a pace more familiar in enterprise technology, while healthcare purchasers need assurance that updates do not change safety or effectiveness in unexpected ways. Certification providers that can process reliable evidence efficiently could make product release cycles more predictable.
Faster processing still has to operate within the requirements of rigorous assessment. Regulators and healthcare systems are likely to judge any new approach by the quality of its assessments, its independence from clients and the traceability of decisions. Using AI to assist assessment also creates questions about governance, accuracy and accountability for the certification body itself.
Scarlet’s investment comes as European and British businesses explore how to build commercial services around new AI applications rather than concentrating investment entirely on model development. Compliance, testing and assurance can be valuable markets in their own right, particularly where customers face legal and reputational consequences from deploying a product without the appropriate approval.
Scarlet’s round adds to international investment in specialist British technology services. Scaling the business will depend on recruiting appropriately qualified assessors, maintaining the necessary regulatory designations and demonstrating consistent assessment outcomes as its client base and range of products grow.
The new capital will allow Scarlet to expand its operations and assessment capacity, although the company must continue to demonstrate regulatory independence and the reliability of its decisions. Manufacturers seeking approval for software-based devices still have to meet applicable safety and performance requirements; faster administration cannot replace the evidence on which certification depends.
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