Scarlet certifies software medical devices for market access. We are Europe's only Notified Body specialising in software and AI.
Rather than demanding traditional, long-form documentation, our process allows customers to submit specific, machine-readable data through structured templates. This means it's much more efficient and enables us to deliver on our mission to hasten the world's transition to accessible healthcare.
Our accreditations
Scarlet is designated as an EU Notified Body under regulation (EU) 2017/745 (EU MDR) and a UK Approved Body under UK Medical Devices Regulations 2002 (SI 2002/618 as amended).
Scarlet is also accredited to issue ISO 13485 certificates.
Our commitment to safety and efficiency
To enable safe medical devices to reach the people who need them:
We have developed specs and workflows that make submitting the right data in the right format easy.
We use structured data to make conformity assessment fast and efficient.
We keep lines of communication as open as possible.
To protect the public from unsafe medical devices:
We demand that the data submitted is high quality and accurate.
If we cannot find evidence that a device is compliant and a manufacturer is taking responsibility for its compliance, we cannot let that device reach the public.
What sets Scarlet apart?
Instead of long-form documentation, Scarlet customers share structured, machine-readable data using the Scarlet submission tool. This has three core benefits:
Speed - Scarlet can automatically validate the data you provide.
Transparency - Scarlet tells you what data it needs to verify compliance, enabling you to know when you're complete and Scarlet to give you live feedback when you're not.
Continuous compliance - Scarlet incorporates new guidance and requirements into our system regularly, so you can be confident that you will always be compliant.
We are excited to support your work and bring safe, innovative healthcare solutions to the people who need them most