Fraiya × Scarlet
Certifying a start-up’s AI medical device for pregnancy ultrasound in under 6 months
How Fraiya engaged in structured dialogues and got their SaMD MDR certified & ready for product-update approvals
“We wanted a Notified Body that would understand our software, 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
- Start-up from King's College London and Guy's & St Thomas' NHS Foundation Trust
- Developing cutting-edge, AI-enabled pregnancy ultrasound
- Seeking AI-specialised Notified Body for EU MDR certification
Impact
- Supports clinicians during the 20-week anomaly scan — automating real-time image acquisition, quality checks, and crucial biometric measurements
- Built from within the NHS, able to integrate into existing scanning workflows and ultrasound infrastructure
The Scarlet Process
Scarlet's AI expertise, structured dialogues, and regular, responsive support led to a certification decision in under six months
How It Worked
To ensure an efficient process, we:
- Used Scarlet’s AI specialists to efficiently understand Fraiya’s product - avoiding needless back and forth
- Used structured dialogues to convey regulatory principles - avoiding wasted effort
- Maintained regular contact with Fraiya to ensure they had full visibility on timelines - avoiding the uncertainty that prevents reliable planning
The Results
Scarlet’s approach resulted in:
- EU MDR certification in under six months
- FraiyaScan can now be sold into UK and EU healthcare systems and reach patients
- Fraiya can update FraiyaScan efficiently as they iterate their AI models and software
“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 do that with.”
Jackie Matthew, Chief Medical Officer & Co-founder, Fraiya
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