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.
Our mission is to hasten the transition to universally accessible healthcare. We are authorised by governments to assess and grant market access to medical AIs. Our groundbreaking approach enables the most innovative technology to reach patients safely and quickly.
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.