Certify your AI medical device without unnecessary delays

Certify your AI medical device without unnecessary delays

Get your life-changing technology to the people who need it, with the only Notified Body specialised in AI and SaMD

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empowering visionary AI innovators

“Scarlet have built a Notified Body for the AI world.”

“We were facing a long and uncertain wait to get a truly ground-breaking device to market. Scarlet’s focus as a Notified Body on AI & SaMD meant we could release it in 

2024 and start changing lives for the better.”

“We were facing a long and uncertain wait to get a truly ground-breaking device to market. Scarlet’s focus as a Notified Body on AI & SaMD meant we could release it in

2024 and start changing lives for the better.”

Finn Stevenson

Co-founder & CEO, Flok Health

Why Scarlet

Medical device certification built for AI

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Fast Assessment

Fast, accurate reviews and prompt query resolution from specialist assessors with AI-enhanced tools.

Floy Heath

Fast Assessment

Fast, accurate reviews and prompt query resolution from specialist assessors with AI-enhanced tools.

Floy Heath

Update your product quickly

Build iteratively and ship frequent releases of your innovative software medical device

Lucida Medical

Update your product quickly

Build iteratively and ship frequent releases of your innovative software medical device

Lucida Medical

Manage multiple devices

Upload any file type, run AI coverage checks, and get dedicated assistance throughout your application

Fraiya

Manage multiple devices

Upload any file type, run AI coverage checks, and get dedicated assistance throughout your application

Fraiya

Our customers

We are proud to empower the companies building the next generation of medical AI

View customer stories

Our customers

We are proud to empower the companies building the next generation of medical AI

View customer stories

Our customers

We are proud to empower the companies building the next generation of medical AI

View customer stories

Watch Skin Analytics story

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“Scarlet have built a Notified Body for the AI world.”

Finn Stevenson

Co-founder & CEO, Flok Health

“We’ve been amazed by Scarlet. We simply couldn't have found a better Notified Body. Their support throughout was incredible.”

Yan Peng Zhao

MDR Compliance Lead, Tandem Health

“It’s great to work with a Notified Body that truly understands AI.”

Claartje Ypma

Co-founder & CEO, Augmedit

“We wanted a Notified Body that would understand our SaMD, and that’s why we chose Scarlet. Their process is aligned to how we develop and update our AI models.”

Sam Budd

CTO & Co-founder, Fraiya

“The transfer to Scarlet was seamless. We received regular updates throughout and always knew what was going on. We had no idea a transfer could be so swift.”

Stefani Aleksandrova

Head of Regulatory Affairs, Lucida Medical

“If you're looking for a Notified Body that understands SaMD then Scarlet is the one to work with.”

James Hamlyn

QA/RA Director, Skin Analytics

Already Certified?

Transfer to Scarlet in 4 weeks

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Designations

We are accredited and regulated by leading government institutions:

faq's

Common questions

Which standards can Scarlet certify against?

Which jurisdictions does Scarlet cover?

Does Scarlet certify hardware medical devices?

What is Scarlet's pricing model?

faq's

Common questions

Which standards can Scarlet certify against?

Which jurisdictions does Scarlet cover?

Does Scarlet certify hardware medical devices?

What is Scarlet's pricing model?

faq's

Common questions

Which standards can Scarlet certify against?

Which jurisdictions does Scarlet cover?

Does Scarlet certify hardware medical devices?

What is Scarlet's pricing model?

Need to certify an AI medical device or SaMD?

Get In Touch