Medical device certification built for software and AI.
We certify SaMD and AIaMD in a way that is optimised for fast-paced development, so you can continuously and predictably get your life-changing technology to the people who need it.
How it works
A structured, specialised approach.
Scarlet combines crafted automation with human assessment expertise.
Our process allows you to submit your technical file in a structured, machine-readable way, while our assessments are performed by SaMD and AI specialists.
This removes unnecessary delays and allows better and safer products to reach more patients.
How we built it
Scarlet was crafted by those at software's intersection with digital healthcare.
Our assessment team includes software engineers and experts in medical AI. We understand your device.
Our process and platform were built accordingly, adapted to the life-cycle of the world's leading medical software.
This means three core benefits for our customers
Efficiency
Scarlet's approach is tailored to software, not hardware, so you avoid the inefficiencies of a system not made for your technology.
Visibility
Scarlet's submission process asks you targeted questions, so you avoid the guesswork and can see when you're done.
Iteration
Scarlet's process constantly incorporates new requirements and isolates relevant changes in new versions of your product, so you are not struggling to make the frequent updates that are essential to the best software and AI.
Need to certify a software medical device?
Schedule a call or demo, or simply ask for more information about Scarlet's process and platform.
FAQ
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Which standards can Scarlet certify against?
Scarlet is accredited to issue ISO 13485:2016 certificates. Scarlet performs conformity assessment against Regulation 2017/745 (EU MDR) Annex IX, and against UK Medical Devices Regulations 2002 (SI 2002/618 as amended).
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Which jurisdictions does Scarlet cover?
Scarlet covers the following jurisdictions:
- Great Britain
- European Union
- Our approvals are also valid in countries that recognise EU MDR such as the EEA countries, Switzerland, and Turkey.
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Does Scarlet certify hardware medical devices?
No, Scarlet only certifies software and AI medical devices.
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What is Scarlet’s pricing structure?
Scarlet charges a flat monthly fee based on the scope of the overall software product you are certifying. This includes access to Scarlet’s interface and all certification services required to place and maintain your product on the market. There are no hidden fees.
