Scarlet

Scarlet — accelerating safe AI healthcare

Scarlet is a mission-driven organisation dedicated to hastening the transition to universally accessible healthcare by enabling developers of AI medical devices and Software as a Medical Device (SaMD) to certify and deliver life‑changing technology without unnecessary delay.

What we do

Scarlet operates a specialised Notified/Approved Body and certification service tailored to AI and SaMD. We provide a certification process designed for frequent, safe iteration so manufacturers can update products predictably and get the most up-to-date technology to patients.

We work with manufacturers and regulators to certify medical devices across jurisdictions, supporting predictable market access for AI-driven health products.

Accreditations, offices & contact

Scarlet is accredited and regulated by multiple national and pan‑government agencies. Key designations include:

EU Notified Body under Regulation (EU) 2017/745 (EU MDR)
UK Approved Body under UK Medical Devices Regulations
ISO 13485 certification capability and ISO 17021-1:2015 accreditation via national bodies (eg. UKAS, RVA)
Authorisations from agencies such as the UK MHRA, Dutch Ministry of Health, and Health Department of the European Commission

Offices: London and Amsterdam. Contact: [email protected]

Careers

Scarlet hires mission-driven experts across regulatory, clinical, engineering and product disciplines. View open roles and application details on our careers page linked below.