Insights

AI MDR niche Scarlet is Europe’s only Notified Body specialized in AI and SaMD, presenting a unique external capability for AI medical device developers seeking EU and UK regulatory certification.

Regulatory leadership With EU MDR Notified Body status and UK Approved Body designation plus ISO 13485 accreditation, Scarlet can be a trusted regulatory partner for AI healthcare startups and established players expanding regulatory acceptance.

Funding traction Moderate revenue range with substantial funding indicates growing demand for AI medical device certification services; potential upsell opportunities as clients scale and pursue broader regulatory compliance.

Security and tech Strong tech and compliance stack including ISO, ISO/IEC 27001, AWS, CDN, and modern web technologies suggests Scarlet can onboard and support clients with stringent data security and performance requirements.

Global expansion readiness London-based with UK and EU regulatory scope positions Scarlet to assist cross-border AI SaMD developers targeting Europe, enabling regional market access and ongoing post-market update certification.

Scarlet Tech Stack

Scarlet uses 8 technology products and services including ISO/IEC 17021, Amazon S3, cdnjs, and more. Explore Scarlet's tech stack below.

ISO/IEC 17021

Certificates

Amazon S3

Content Delivery Network

cdnjs

Content Delivery Network

AOS

Javascript Libraries

PWA

Miscellaneous

Priority Hints

Performance

Google Analytics

Web Analytics

Google Search Console

Web Analytics

Scarlet Email Formats	Example	Percentage
First@scarletcomply.com	John@scarletcomply.com	100%
First.Last@scarlet.cc	John.Doe@scarlet.cc	100%

Scarlet Email Formats

Example

Percentage

First@scarletcomply.com

John@scarletcomply.com

100%

First.Last@scarlet.cc

John.Doe@scarlet.cc

100%

Frequently Asked Questions

What is Scarlet's official website and social media links?

Scarlet's official website is scarlet.cc and has social profiles on LinkedIn Crunchbase.

How much revenue does Scarlet generate?

As of July 2026, Scarlet's annual revenue is estimated to be $1M - $10M.

What is Scarlet's NAICS code?

Scarlet's NAICS code is 62 - Health Care and Social Assistance.

How many employees does Scarlet have currently?

As of July 2026, Scarlet has approximately 86 employees across 5 continents, including EuropeAsiaNorth America. Key team members include Chief Of Staff: E. O.Head Of Devices: S. W.Head Of Quality: F. A.. Explore Scarlet's employee directory with LeadIQ.

What industry does Scarlet belong to?

Scarlet operates in the Hospitals and Health Care industry.

What technology does Scarlet use?

Scarlet's tech stack includes ISO/IEC 17021Amazon S3cdnjsAOSPWAPriority HintsGoogle AnalyticsGoogle Search Console.

What is Scarlet's email format?

Scarlet's email format typically follows the pattern of First@scarletcomply.com. Find more Scarlet email formats with LeadIQ.

How much funding has Scarlet raised to date?

As of July 2026, Scarlet has raised $27M in funding. The last funding round occurred on Jun 14, 2024 for $18M.

When was Scarlet founded?

Scarlet was founded in 2020.

Scarlet

Q: What is Scarlet's official website and social media links?

Scarlet's official website is scarlet.cc. Scarlet has social profiles on LinkedIn.

Q: How many employees does Scarlet have currently?

Scarlet has approximately 86 employees.

Q: What technology does Scarlet use?

Scarlet's tech stack includes JavaScript, PHP, ISO/IEC 27001, JSON-LD, html5media.

Q: What is Scarlet's NAICS code?

Scarlet's NAICS code is 62 (Health Care and Social Assistance).

Hospitals and Health CareEngland, United Kingdom51-200 Employees

Scarlet, based in London, England, operates in the Hospitals and Health Care sector as a regulatory partner for AI-based medical devices. It certifies SaMD and is designated as Europe’s only Notified Body specializing in AI and SaMD, with EU MDR designation and UK Approved Body status. The company is also accredited to issue ISO 13485 certificates, supporting customers as they bring their products to EU and UK markets and manage regular software updates essential to AI-enabled devices. 

Its customers are developers and manufacturers of AI-powered medical devices seeking regulatory clearance and ongoing compliance. Scarlet guides them through SaMD certification and market access in the EU and UK, enabling safe release and maintenance of up-to-date AI functionality. By focusing on AI medical devices and regulatory pathways, Scarlet aims to help broaden access to healthcare by ensuring patients receive regulated, current technology.

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