Scarlet is a mission-driven organisation dedicated to transforming global healthcare.

We help customers certify their software medical devices without unnecessary delays, enabling the rapid and frequent iteration needed for the best software and AI medical devices.

Our mission is to hasten the transition to universally accessible healthcare.

We deliver on our mission by enabling our customers to increase access to safe, compliant, and effective software and AI medical devices.

We work with visionary medical device manufacturers, empowering innovators to safely get the latest versions of their products to the people who need them.

Scarlet is designated as an EU Notified Body under Regulation (EU) 2017/745 (EU MDR).

Scarlet is designated as a UK Approved Body under UK Medical Devices Regulations 2002 (SI 2002/618 as amended).

Scarlet is accredited to issue ISO 13485 certificates.

Scarlet is authorised and regulated to certify software and AI medical devices by major government agencies including UKAS, RVA, Dutch Ministry of Health, UK Medicines and Healthcare products Regulatory Agency, and the Health Department of the European Commission.