Scarlet

Scarlet is a certification body (Notified Body) for AI and software-as-a-medical-device (SaMD). Its website describes services for certifying devices under EU MDR, covering iterative releases, adding devices to a product line, and transferring existing certificates to Scarlet.

Its customers are developers of medical AI and SaMD products, and the website lists customer stories including Flok Health, Lucida Medical, Floy, Tandem Health, Augmedit, Fraiya and Skin Analytics. The website does not describe its fee structure in the captured text, although a pricing FAQ is listed.

The company states it is accredited and regulated by government institutions, but the captured text does not name them. Its advisors include a former MHRA medical devices director and a former CEO of BSI, and it has an independent Impartiality Panel. Office locations listed in its job postings are London, New York City and Stockholm. A blog post dated 12 October 2026 refers to a $50m Series B, and the careers page lists 14 open roles across sales, devices auditing, engineering, machine learning, product design and commercial relations. The founding year is not stated.

Product: Notified Body conformity assessment and certification of AI and software medical devices under EU MDR, including certificate transfers.