Scarlet

Scarlet is Europe's only Notified Body specializing in the certification of software and AI as medical devices. The company streamlines the certification process for Software as a Medical Device (SaMD) and AI-based Medical Devices (AIaMD), helping manufacturers bring their innovative solutions to market efficiently. Scarlet's mission is to facilitate the transition to universally accessible healthcare by enabling their clients to meet regulatory standards without unnecessary delays. By focusing on specialized processes for software and AI technology, Scarlet aims to enhance the overall quality and availability of healthcare solutions.