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
Experts & AI
Scarlet's world-leading medical-software specialists leverage AI.
You can submit your files, in your format, and benefit from efficient assessments performed by SaMD experts.
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.
Welcome to your Scarlet workspace
SCARLET DRIVE
Upload your files in any format.
Avoid the hassle of reformatting data,
and 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 show you exactly what’s needed, when it’s needed.
SNAPSHOTS
Crisp submission versioning.
Avoid digging through your emails and comparing previous versions, respond to requests confidently and quickly.
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.
