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.
Expertise
Unbeatably efficient
Our team is composed of doctors and engineers who deeply understand your technology, and they are armed with Scarlet’s in-house AI tools.
This combination makes your conformity assessment unbeatably efficient.
Progress
Responsive & clear
Speak regularly with our experts and get timely requests from our app.
So you know what's happening and can always report on progress.
Efficiency
No unnecessary delays
Scarlet gets even Class III products to market within six months, and completes certificate changes in two weeks.
So you can be sure you won’t miss your deadlines.
Welcome to your Scarlet workspace
Coverage
Get automated analysis on your submission
Avoid the uncertainty — know where you stand with our AI-powered coverage check.
SCARLET DRIVE
Upload your files in any format.
Avoid the hassle — no need to reformat your data, work with Scarlet your way, directly in your own dedicated workspace.
REQUESTS
Clear expectations and frequent interactions.
Avoid the guesswork — receive requests that take you through the process and ask for exactly what’s needed, when it’s needed.
Need to certify a software medical device?
Schedule a call, or simply ask for more information about Scarlet.
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 model?
Scarlet charges a flat monthly fee based on the scope of the overall software product you are certifying. This fee includes all certification services required to place and maintain your product on the market — there are no hidden fees.
This means:
You get complete cost predictability — so your Finance team won't be hit with nasty surprises.
You avoid misaligned incentives — we don’t bill by the hour, we’re fully focused on efficient and exceptional service.
You can update your device without friction — all certificate changes are included, so your Product team isn’t held back by uncertain regulatory costs.
