Scarlet

Scarlet, founded in 2020, is positioned uniquely in the healthcare sector as Europe’s only Notified Body specialised in software and AI. Headquartered in the United Kingdom, the company plays a crucial role in certifying software medical devices, focusing on the rapidly growing domain of Software as a Medical Device (SaMD).

The company is dedicated to accelerating the transition to accessible, affordable healthcare. By enabling clients to achieve certification for their life-saving technologies in the EU and UK, Scarlet ensures that patients have access to the most up-to-date software-driven medical solutions.

Strategically accredited, Scarlet is recognized as an EU Notified Body under Regulation (EU) 2017/745 (EU MDR) and a UK Approved Body, also authorized to issue ISO 13485 certificates. This strong regulatory foothold underscores its market strength.

Its most recent funding came from a £6M Seed Round on 30 August 2022, with support from notable investors Kindred Capital and Creandum, highlighting confidence in its vision and specialized market presence.