Scarlet is Europe's sole Notified Body dedicated to software and AI medical devices, providing certification under EU MDR and UK MDR, as well as ISO 13485 accreditation. The company specializes in certifying SaMD and facilitating the safe deployment of regular software updates, ensuring patients receive the latest, life‑changing technology. By partnering with developers, Scarlet accelerates the transition to universally accessible healthcare and supports clients in meeting regulatory requirements efficiently. Its mission‑driven culture emphasizes innovation, safety, and rapid delivery of transformative medical solutions.
We are creating a network of clinical specialists who can provide targeted clinical insight on medical devices during regulatory assessments. Your input helps ensure that certified devices demonstrate appropriate clinical performance, safety, and benefit for their intended clinical use.
Scarlet is Europe's sole Notified Body dedicated to software and AI medical devices, providing certification under EU MDR and UK MDR, as well as ISO 13485 accreditation. The company specializes in certifying SaMD and facilitating the safe deployment of regular software updates, ensuring patients receive the latest, life‑changing technology. By partnering with developers, Scarlet accelerates the transition to universally accessible healthcare and supports clients in meeting regulatory requirements efficiently. Its mission‑driven culture emphasizes innovation, safety, and rapid delivery of transformative medical solutions.
Scarlet