Scarlet

Scarlet is a mission-driven organisation that hastens the transition to universally accessible healthcare by enabling manufacturers to certify software and AI medical devices without unnecessary delays. We specialise in certification for Software as a Medical Device (SaMD) and AI, providing a process designed for frequent, safe updates so life-changing technology can reach patients reliably and predictably.

What we do

We operate as a specialised Notified/Approved Body and certification provider for software and AI medical devices. Scarlet is designated under EU Regulation 2017/745 (EU MDR), is an approved body under UK medical device regulations, and is accredited to issue ISO 13485 certificates. We are authorised and recognised by national bodies including UKAS, RVA, the UK Medicines and Healthcare products Regulatory Agency (MHRA), and relevant ministries of health in Europe.

Careers & contact

Scarlet is headquartered across London and Amsterdam and hires experts in regulatory, clinical, and software/AI domains. For current openings see our jobs page. For general enquiries contact [email protected].