Fraiya × Scarlet
Certifying a start-up’s AI obstetric ultrasound device
“We wanted a Notified Body that would understand our SaMD, and that’s why we chose Scarlet. Their process made everything clear, and was aligned to how we develop and update our AI models. With CE marking achieved, we’re now moving fast towards real-world impact in prenatal care.”
Sam Budd
CTO & Co-founder, Fraiya
The Challenge
Fraiya needed a Notified Body with AI expertise to get FraiyaScan onto the UK & EU markets efficiently, and be able to release updated versions of their device
Customer Snapshot
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Start-up from King's College London and Guy's & St Thomas' NHS Foundation Trust
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Developing cutting-edge, AI-enabled pregnancy ultrasound that supports clinicians during the 20-week anomaly scan, automating real-time image acquisition, quality checks, and crucial biometric measurements
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Seeking AI-specialised Notified Body for EU MDR certification
The Scarlet Process
Fraiya benefitted from Scarlet's AI expertise, structured dialogues, and regular, responsive support
Scarlet’s approach resulted in:
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EU MDR certification for a ground-breaking AI device
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FraiyaScan can now be sold into UK and EU healthcare systems, integrate into existing scanning workflows and ultrasound infrastructure, and reach patients
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Fraiya can update FraiyaScan efficiently as they iterate their AI models
“That’s what’s great about working with Scarlet, FraiyaScan is an AI medical device, so we want to update it regularly and we know they’re the right Notified Body to facilitate that.”
Jackie Matthew
Chief Medical Officer & Co-founder, Fraiya
