Transfer your MDR certificates to a Notified Body that understands AI & SaMD

transfers

Scarlet is built for AI & SaMD, so you avoid delayed & frustrating processes, get clear feedback from software & AI experts, and undergo your audits remotely.

how it works

You can easily transfer your AI/SaMD certificates to Scarlet

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You get a customised transfer plan aligned to your existing surveillance schedule

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You receive support from Scarlet throughout, including with communication to your existing Notified Body

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You transfer your EU MDR and/or ISO 13485 certificate in four weeks

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

“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.”

Stefani Aleksandrova

Head of Regulatory Affairs, Lucida Medical

As a Scarlet customer you get:

Specialisation

Our approach is tailored to AI, so you avoid the frustration of a system not made for your technology.

Specialisation

Our approach is tailored to AI, so you avoid the frustration of a system not made for your technology.

Expertise

Our assessors are AI & SaMD experts, meaning you avoid painful back and forth explaining your product.

Expertise

Our assessors are AI & SaMD experts, meaning you avoid painful back and forth explaining your product.

Frictionless updates

Our deep knowledge and specialised processes allow you to make frequent updates to your AI models without friction.

Frictionless updates

Our deep knowledge and specialised processes allow you to make frequent updates to your AI models without friction.

“Our MDR certificate change with Scarlet was astonishingly efficient. It took just two weeks and incurred no extra costs whatsoever. This is a game changer for innovative AI medical device companies like Feebris.”

“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.”

Adam Bacon

Co-founder, Feebris

Need to certify an AI medical device or SaMD?

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Transfer your MDR certificates to a Notified Body that understands AI & SaMD