Scarlet

Saltsjöbaden · est. 2025 · website↗

Registered as Scarlet Holding AB

Scarlet certifies AI medical devices. Get your life-changing technology to the people who need it, with the global AI certification body. We pull medical technology from the future to solve human health. We believe healthcare can be solved by the next generation of medical technology. Our mission is to pull those devices from the future into today. We remove unnecessary delays from every regulatory approval we do so people can access devices right now that would otherwise not be available. Scarlet was built specifically for AI medical devices. We help customers to get their medical AI certified and to ship the kind of iterative updates inherent to the best AI products, ensuring patients can safely get the most up-to-date technology. Scarlet performs conformity assessment against EU MDR, UK MDR, and is recognised by the FDA as a Third Party Review Organisation (3P510k). We also issue ISO 13485 certificates, ISO/IEC 27001 certificates, ISO/IEC 42001 certificates, and support international certification under the Medical Device Single Audit Program (MDSAP).