Scarlet

What Scarlet does

Scarlet is a privately-held Notified Body headquartered in London, founded in 2020, that operates as Europe's only certification body specialized in Software as a Medical Device (SaMD) and AI-based medical devices. Through its operating subsidiaries Scarlet NB B.V. (Netherlands) and Scarlet NB UK Ltd, the company issues conformity assessment certificates under EU MDR (Regulation 2017/745), UK MDR, ISO 13485 (quality management), ISO 27001 (information security), and ISO 42001 (AI management system), covering medical devices from Class Im through Class III. Scarlet positions itself around deep assessor expertise in iterative AI development, enabling AI medical device manufacturers to ship frequent model updates without the certification bottlenecks typical of traditional Notified Bodies.

The company's proprietary Scarlet Application Portal serves as the operational backbone for submissions, compliance data exchange, and ongoing certificate management. Its core products are AI Medical Device Certification Services and a Certificate Transfer Service offering a 4-week migration path from competing Notified Bodies. Revenue is generated through two streams: one-time Initial Certification Fees (typically starting at €100,000 for EU/UK MDR plus ISO 13485) and recurring Annual Service Fees at a €5,000/month equivalent, billed monthly under multi-year contracts. The pricing model is transparent and fixed, with size-based adjustments for SMEs.

Scarlet targets AI medical device manufacturers and healthcare AI startups, primarily in the EU and UK markets, via a sales-led enterprise GTM motion delivered through its website contact forms and scheduled calls. Named customers include Flok Health, Lucida Medical, Skin Analytics, Feebris, Augmedit, Tandem Health, Fraiya, and Floy. The company has raised approximately $26.5M across three funding rounds (2021 seed, 2022 seed extension led by Creandum, 2024 Series A led by Atomico) and operates with 51-100 employees based across the UK, EU, and US.

Name

Scarlet

Legal name

Scarlet Global Holdings Ltd

Website

https://scarlet.cc

Company type

Private

Founded year

2020

Operating status

Operating

Headcount range

51–100 employees

Short description

Scarlet is Europe's only Notified Body specialized in AI and Software as a Medical Device (SaMD), certifying AI medical devices under EU MDR, UK MDR, and ISO standards for AI medical device manufacturers and healthcare startups.

Ownership category

akta.pro rank

Product category

Medical Device Certification & Regulatory Compliance Services

NAICS

Testing Laboratories and Services (541380)

SIC

Services-Testing Laboratories (8734)

akta.pro primary industry

DTx/SaMD Regulatory, Quality & Compliance Software (QMS/ISO/FDA) (HLACANAN)

akta.pro secondary industry

Regulatory Readiness & Audit Automation (e.g., EU AI Act, NIST AI RMF, ISO/IEC 42001) (HDAAAMAE)

Keywords

• Medical device certification
• AI medical device conformity
• EU MDR Notified Body
• SaMD regulatory assessment
• ISO 13485 certification

Headquarters

HQ city

London

HQ country

United Kingdom

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales, Others

Revenue model

1. Initial Certification Fees: One-off fees covering assessment and decision for initial certificate. Paid partially at service start and in full once Initial Application has been submitted and accepted. Calculated based on scope of certificate sought (certificate type, organization size, product scope, risk class). Typically starts from €100,000 for EU or UK MDR plus ISO 13485.
2. Annual Service Fees: All-inclusive ongoing service fees covering product updates and surveillance activities. Paid in monthly installments from service start. Covers all maintenance activities including audits, change request processing, and support for the lifetime of the certificate. Calculated based on scope of ongoing services, typically starting at €5,000 per month equivalent.

Pricing tiers

Go-to-market motion2 records

Distribution channels2 records

Marketing channels5 records

Core offering

Scarlet is a Notified Body that provides conformity assessment and certification services for AI-based medical devices and Software as a Medical Device (SaMD) under EU MDR, UK MDR, ISO 13485, ISO 27001, and ISO 42001. The offering is purpose-built for AI manufacturers needing iterative model updates, with a specialized application portal, remote audits, transparent fixed-fee pricing, and a streamlined 4-week transfer process for certificates issued by other Notified Bodies.

Product overview

Scarlet is the only Notified Body specialized in AI and Software as a Medical Device (SaMD), offering conformity assessment services for EU MDR, UK MDR, ISO 13485, ISO 27001, and ISO 42001 certifications. The core offering consists of AI Medical Device Certification Services, which provide a streamlined path to certification designed for iterative software development. A supplementary Certificate Transfer Service enables manufacturers to transfer existing certificates in four weeks. Customers interact with the platform through Scarlet's Application Portal. The company also provides LLM Guidance Resources and publishes Customer Stories documenting successful certifications across diverse AI medical device categories including radiology, dermatology, surgery, and diagnostics.

Differentiator

Problem solved

Functional benefit

Products and services

• AI Medical Device Certification Services Conformity assessment services for AI medical devices and Software as a Medical Device (SaMD) under EU MDR, UK MDR, ISO 13485, ISO 27001, and ISO 42001, covering Class Im, IIa, IIb, and III devices, with assessment processes designed for iterative AI model updates and frequent software releases. Targeted at AI medical device manufacturers seeking EU and UK market access.
• Certificate Transfer Service Dedicated transfer service for manufacturers already certified by another Notified Body, providing a customized transfer plan aligned to existing surveillance schedules and a streamlined 4-week timeline for EU MDR, UK MDR, and/or ISO 13485 certificates. Targets manufacturers dissatisfied with timelines or AI expertise at their current body.

Quantifiable outcome

• 14 weeks to EU MDR certification for AI physiotherapy device (Flok Health)
• +5 more outcomes

Named customers10 records

Segments3 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Scale indicators3 records

Recent moves7 records

Expansion highlights5 records

Broad incumbents

• BSI Group: BSI is one of the largest and longest-established Notified Bodies in the UK/EU for medical devices, including SaMD and AI-enabled devices. It is a direct comparator because Scarlet's former BSI CEO (Howard Kerr) is on its advisory bench, and BSI is the established player Scarlet is most directly taking share from in AI/SaMD certification.
• TÜV SÜD: TÜV SÜD is a major German-headquartered Notified Body designated under EU MDR with broad medical device certification capabilities, including digital health and software. Comparable to Scarlet as a regulated conformity assessment body for medical devices, but operating across a much broader portfolio of standards and industries.
• TÜV Rheinland: TÜV Rheinland is a global testing, inspection, and certification organization with a designated Notified Body under EU MDR. Comparable to Scarlet in the conformity assessment process for medical devices but as a much larger generalist serving multiple industries and standards beyond SaMD/AI.
• DEKRA: DEKRA is a large European testing and certification organization expanding into medical device certification, including SaMD. It competes with Scarlet as a notified/regulated assessment body for medical devices but from a much broader testing, inspection, and certification portfolio.
• Eurofins Scientific: Eurofins is a large testing services group that has expanded into medical device testing and certification-adjacent services. Comparable to Scarlet in providing regulated testing/assessment services to medical product manufacturers, though Eurofins is much broader and not specifically a Notified Body for SaMD.
• Intertek Group: Intertek is a global assurance, inspection, and product testing company with medical device testing services. Comparable to Scarlet in providing independent third-party assessment services that support regulatory market access, but as a diversified generalist across many product categories.
• SGS Group: SGS is one of the world's largest testing, inspection, and certification companies, with medical device certification capabilities. Comparable to Scarlet as a regulated third-party conformity assessment provider, though at much larger scale and broader industry coverage.
• Element Materials Technology: Element provides testing and certification services including for medical devices and life sciences. Comparable to Scarlet as a regulated testing/certification services provider to manufacturers seeking market access, though Element is heavily weighted toward materials and product testing rather than SaMD specialization.

Direct peers

• NSAI (National Standards Authority of Ireland): NSAI operates a Notified Body for medical devices under EU MDR. It is comparable to Scarlet as a smaller, designated Notified Body competing in the same medical device conformity assessment market in Europe, though with less AI/SaMD specialization.

Emerging players

• Nelson Labs (Sotera Health): Nelson Labs provides laboratory testing services specifically for the medical device and pharmaceutical industries. Comparable to Scarlet in serving medical device manufacturers seeking third-party testing/certification support, though focused on lab-based sterility and biocompatibility testing rather than software/AI conformity assessment.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks5 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/scarlet-comply

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Subsidiaries2 records

Funding overview

Funding rounds3 records

Investors4 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Scarlet