Scarlet Email Format
Hospitals and Health CareEngland, United Kingdom51-200 Employees
Scarlet, based in London, England, operates in the Hospitals and Health Care sector as a regulatory partner for AI-based medical devices. It certifies SaMD and is designated as Europe’s only Notified Body specializing in AI and SaMD, with EU MDR designation and UK Approved Body status. The company is also accredited to issue ISO 13485 certificates, supporting customers as they bring their products to EU and UK markets and manage regular software updates essential to AI-enabled devices. Its customers are developers and manufacturers of AI-powered medical devices seeking regulatory clearance and ongoing compliance. Scarlet guides them through SaMD certification and market access in the EU and UK, enabling safe release and maintenance of up-to-date AI functionality. By focusing on AI medical devices and regulatory pathways, Scarlet aims to help broaden access to healthcare by ensuring patients receive regulated, current technology.