Scarlet

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.

Our customers work on health conditions impacting hundreds of millions of people, and we support them in delivering the best technology to market safely, predictably, and continuously.

Mission

Our mission is to hasten the transition to universally accessible healthcare by enabling our customers to increase access to safe and effective software and AI medical devices.

The single biggest blocker to innovation in healthcare is the time it takes to safely bring new products to market, especially for AI and software which require frequent updates.

We work with visionary medical device manufacturers to empower the next generation of medical software and help them safely get the latest versions of their products to the people who need them.

Certifications and Accreditations

Scarlet is designated as an EU Notified Body under Regulation (EU) 2017/745 (EU MDR) and as a UK Approved Body under UK Medical Devices Regulations 2002 (SI 2002/618 as amended).

We are accredited to issue ISO 13485 certificates and certified by national accreditation agencies including UKAS and RVA.

We are authorised and regulated to certify software and AI medical devices by major government agencies including the Dutch Ministry of Health, Welfare and Sport, the UK Medicines and Healthcare products Regulatory Agency, and the Health Department (DG-Santé) of the European Commission.

Team and Advisors

The company is led by a world-class team of uniquely skilled experts based in London and Amsterdam, driven by the mission of advancing healthcare.

We are supported by highly qualified advisors with significant experience, including former directors of major regulatory agencies.

Careers and Culture

Scarlet hires talented individuals passionate about delivering the future of healthcare. The company culture values problem-centricity, high performance, and trust.