Scarlet
Entrepreneur First '21London, GB · Founded 2021 · 6 known investors
Scarlet is a certification body (Notified Body) that provides medical device certification for AI-based devices, including under EU MDR. It serves AI medical device developers, offering fast certification, support for iterative product updates, and certification of multiple devices.
Founders & leadership
Scarlet was founded in 2021 by James Dewar and Jamie Cox.
Investors · 6
Company profile
researched Aug 2026Scarlet is a medical device certification body (notified body) focused on AI-based and software-as-a-medical-device (SaMD) products. Its stated positioning is to provide global medical device certification designed around how AI products are built and updated, with the aim of removing delays from regulatory approval so devices reach patients sooner. The company's website groups its offering around three propositions: certifying a device quickly by working with assessors who understand the underlying technology, supporting frequent releases and iterative model updates after certification, and adding further devices for companies expanding an AI device suite.
Scarlet also markets a transfer service for manufacturers that already hold certificates with another notified body, advertising a four-week transfer timeline. It states that it is accredited and regulated by government institutions, though the specific designations are not enumerated in the retrieved material. The company publishes a regulatory-technical blog covering topics such as risk management for machine learning medical devices (ISO/TS 24971-2), unique device identification (UDI) assignment for software and AI devices, post-market clinical follow-up (PMCF) for AI devices, and medical device cybersecurity under EU MDR (IEC 81001-5-1). Its mission page frames the objective as pulling future medical technology into the present by removing unnecessary regulatory delay.
Scarlet appears in the Entrepreneurs First portfolio, categorised under Enterprise Services and Healthcare, based in London and founded in 2021, with James Dewar as CEO and Jamie Cox as CTO, and Creandum named as a funder.
Business model
Scarlet operates as a third-party conformity assessment/certification body (notified body) for medical device manufacturers, assessing and certifying devices and also accepting transfers of certificates issued by other notified bodies. The website references a pricing model in its FAQ section, but the retrieved content does not disclose its terms.
Traction
The website features named customer references and testimonials from Flok Health, Tandem Health, Augmedit, Fraiya, Lucida Medical, Floy and Skin Analytics, including at least one certificate transfer from another notified body (Lucida Medical). No customer counts, certificate volumes or financial metrics are disclosed in the sources.
Latest developments
The company's blog carried posts dated 26 June 2026, 17 July 2026, 30 July 2026 and 20 August 2026 on regulatory topics including IEC 81001-5-1 cybersecurity under EU MDR, PMCF for AI devices, UDI assignment for software and AI devices, and ISO/TS 24971-2 risk management for machine learning devices.
▸Full profile — market position, go-to-market, geography, risks & controversies
Market position
Scarlet positions itself as a notified body purpose-built for AI and software medical devices, contrasting its approach with conventional certification bodies through customer statements referring to alignment with iterative AI model development and rapid certificate transfers. A customer quote on its site describes it as "a Notified Body for the AI world."
Stated points of difference are speed of certification, assessors familiar with AI/SaMD technology, accommodation of frequent product releases and model updates, capacity to certify multiple devices within a product suite, and a four-week certificate transfer process.
Go-to-market
Direct enquiry-led sales via the company website ("Get in touch" and "Start your transfer" calls to action), supported by published customer stories and video case studies, plus a technical content blog on medical device regulatory topics.
Developers and manufacturers of AI-based and software medical devices. Named customers and testimonial sources include Flok Health, Lucida Medical, Floy, Skin Analytics, Tandem Health, Augmedit and Fraiya.
Geography
Headquartered in London, United Kingdom. The website describes Scarlet as a global AI certification body and references coverage of multiple jurisdictions and standards in its FAQ, though the specific jurisdictions are not detailed in the retrieved content.
Risks & controversies
No controversies are reported in the retrieved sources. Note that several similarly named entities exist and were excluded: Scarlet Therapeutics, a University of Bristol biotechnology spin-out developing red blood cell therapies, and Scarlet, the Belgian/Dutch low-cost telecommunications brand owned by Proximus Group.
Compiled by commissioned research from 8 cited public sources — announcements, filings, and press listed under research sources below.
Key figures
latest reportedCompany-reported or press-reported figures, each dated to when it was claimed — not independently audited.
In the news
▸Research sources · 8
primary sources listed
- Scarletscarlet.cc · web
8 public sources were cited for this profile; the first-party ones are listed here.
Frequently asked questions
- What does Scarlet do?
- Scarlet is a London-based notified body certifying AI and software medical devices for market access.
- Who founded Scarlet?
- Scarlet was founded by James Dewar, Jamie Cox in 2021.
- Who are Scarlet's investors?
- Scarlet's investors include Entrepreneur First, Kindred Capital, Atomico, Creandum, Kindred Capital, Science Creates Ventures.
- Where is Scarlet headquartered?
- Scarlet is headquartered in London, GB.