Scarlet

Scarlet certifies AI medical devices. We are Europe’s only Notified Body specialised in AI & SaMD. Our mission is to hasten the transition to universally accessible healthcare.

We strive to achieve our mission by enabling our customers to deliver on theirs, and get their life-changing technology to the people who need it. Scarlet was built specifically for AI medical devices.

We help customers to get their SaMD certified in the EU & UK, and to ship the kind of regular updates inherent to the best AI, ensuring patients can safely get the most up-to-date technology. Scarlet is designated as an EU Notified Body under regulation (EU) 2017/745 (EU MDR).

And a UK Approved Body under UK Medical Devices Regulations 2002 (SI 2002/618 as amended). Scarlet is also accredited to issue ISO 13485 certificates.