Transfer your MDR certificates to a Notified Body that understands AI.
Scarlet is built for AI — so you avoid delayed & frustrating processes, get clear feedback from AI experts, and undergo your audits remotely.
How it works
You can easily transfer your AI/SaMD certificates to Scarlet
- You get a customised transfer plan aligned to your existing surveillance schedule
- You receive support from Scarlet throughout, including with communication to your existing Notified Body
- You transfer your EU MDR and/or ISO 13485 certificate in four weeks
Transfer
“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 the transfer could be so swift.”
Stefani Aleksandrova, Head of Regulatory Affairs, Lucida Medical
Product updates
"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."
Adam Bacon, Co-founder, Feebris
Start your transfer now
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.
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.
Need to certify an AI medical device or SaMD?
Schedule a call, or simply ask for more information about Scarlet.
