Scarlet

Company profile

Company Overview

Scarlet is a mission-driven organisation focused on transforming global healthcare.

The company's daily decisions are guided by a long-term vision to hasten the transition to universally accessible healthcare.

Mission

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

Scarlet empowers visionary medical device manufacturers producing the next generation of medical software, ensuring the safe and timely certification of their products.

Accreditations and Designations

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).

It is also accredited to issue ISO 13485 certificates and is authorised by major government agencies including UKAS, RVA, Dutch Ministry of Health, the UK Medicines and Healthcare products Regulatory Agency (MHRA), and the European Commission.

Team and Advisors

Scarlet is led by a world-class team with offices in London and Amsterdam, supported by highly qualified advisors with extensive experience in medical device regulation and healthcare.