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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Get in touch

empowering visionary AI innovators

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

Finn Stevenson

Co-founder & CEO, Flok Health

Why Scarlet

Medical device certification built for AI

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Certify your device fast

Avoid unnecessary delays, working with a Notified Body that understands your technology

See Flok Health's story

Certify your device fast

Avoid unnecessary delays, working with a Notified Body that understands your technology

See Flok Health's story

Update your device quickly

Ship frequent releases with a Notified Body that understands the importance of iterative product development

See Lucida Medical's story

Update your device quickly

Ship frequent releases with a Notified Body that understands the importance of iterative product development

See Lucida Medical's story

Add multiple devices

Expand your product line fast with a Notified Body that understands AI device suites

See Floy's story

Add multiple devices

Expand your product line fast with a Notified Body that understands AI device suites

See Floy's story

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

Common questions

Which jurisdictions does Scarlet cover?

Which standards can Scarlet certify against?

What is Scarlet's pricing model?

Can I transfer my existing certificates to Scarlet?

faq

Common questions

Which jurisdictions does Scarlet cover?

Which standards can Scarlet certify against?

What is Scarlet's pricing model?

Can I transfer my existing certificates to Scarlet?

faq

Common questions

Which jurisdictions does Scarlet cover?

Which standards can Scarlet certify against?

What is Scarlet's pricing model?

Can I transfer my existing certificates to Scarlet?

Need to certify an AI medical device or SaMD?

Get In touch