Scarlet
Scarlet is a European Notified Body specialised in software and AI medical devices, also an MHRA-approved body and FDA-recognised third-party reviewer.
Position in SVTRnew
Snapshot 2026-10-13- Startup SignalsTop 50%
- Security & ComplianceTop 25%
- Medtech Device#7of 35
About
Scarlet is a European Notified Body specialised in software and AI medical devices, also an MHRA-approved body and FDA-recognised third-party reviewer. It runs a purpose-built certification pathway for SaMD/AIaMD makers, using its own platform to standardise submissions and automate completeness checks, serving medical AI companies such as Tandem Health, Skin Analytics and Lucida Medical.
Full tier & rationale — an SVTR Intelligence benefit
Capital graph
Founders / core team
Investors
Funding history
- 2026-10-13Series B$50M
Investors · Headline、Notion Capital、Atomico、Creandum、Kindred Ventures、Entrepreneur First
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