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Scarlet

Company profile

Company Overview

Scarlet is a mission-driven organisation dedicated to transforming global healthcare by enabling the certification of software and AI medical devices without unnecessary delays. Their specialised certification process is designed for Software as a Medical Device (SaMD) manufacturers, helping bring life-changing medical technology safely and predictably to market.

Mission

Scarlet's mission is to hasten the transition to universally accessible healthcare. They achieve this by empowering their customers to deliver on their missions, increasing access to safe and effective software and AI medical devices worldwide.

Accreditations and Regulation

Scarlet is accredited and regulated by prominent agencies including the UKAS, Dutch Accreditation Council, Inspectie Gezondheidszorg, UK Medicines and Healthcare products Regulatory Agency (MHRA), and the European Commission. They hold designations as an EU Notified Body under Regulation (EU) 2017/745 (EU MDR) and as a UK Approved Body under UK Medical Devices Regulations 2002.

Team and Advisory

Scarlet is led by a team of highly skilled experts and supported by notable advisors with extensive experience in medical device regulation and standards, including former directors and CEOs of major healthcare regulatory agencies and standard organizations.

Scarlet job posts