Transfer your MDR certificates to a Notified Body that understands medical 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 in communication with your existing Notified Body
- You transfer your EU MDR and/or ISO 13485 certificate in a matter of weeks
As a Scarlet customer you get
Specialisation
Our approach is tailored to software, not hardware, 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 demo, or simply ask for more information about Scarlet's process and platform.
