Transfer your MDR certificates to a Notified Body that understands software.
Scarlet is built for SaMD — so you avoid delayed & frustrating processes, get clear feedback from software & AI experts, and undergo your audits remotely.
How it works
You can transfer your SaMD certificates to Scarlet seamlessly
- 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
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, Feebris Co-founder
As a Scarlet customer you get:
Specialisation
Our approach is tailored to software and AI, so you avoid the frustration of a system not made for your technology.
Expertise
Our assessors are SaMD & AI experts, meaning you avoid painful back and forth explaining your software product.
Frictionless updates
Our deep knowledge and specialised processes allow you to make frequent updates to your software and AI models without friction.
Need to certify or transfer a software medical device?
Schedule a call, or simply ask for more information about Scarlet.
