A photo showing medical software on a tablet that is analysing an MRI of a patients lung for signs of cancer lesions. This software could have been certified by Scarlet.

Get your life‑changing technology to the people who need it.

Scarlet certifies Medical Software. We are accredited and regulated by:

UKAS Management Systems. Dutch Accreditation Council. Inspectie Gezondheidszorg en Jeugd, onderdeel van Ministerie van Volksgezondheid, Welzijn en Sport. UK Government organisation, Medicines and healthcare products regulatory agency. European Commission.

Certifying the medicine of the 21st century

Software is the future of health and medicine – but the current regulatory environment wasn’t designed for it.

Scarlet has been built from the ground up by software and AI experts to enable certification of Software Medical Devices. Our framework provides manufacturers and regulators with a way to build and surveil software products in a continuous and scalable way.

This allows better and safer products to reach more patients, taking us one step closer to accessible, affordable healthcare for everyone, everywhere.

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How it works

An illustration showing ideas for an app that helps diagnose medical conditions. Next to it is a phone running the finished app based on those ideas.

Unlock innovation

Get new, life-changing ideas to market.

An illustration showing the results of a compliance assessment. The Hazards section of the application has not met the criteria.

Mitigate risk

Identify issues early and release the safest version of your product.

An illustration showing automated data checks being run on an application, and a notice saying that the ‘Accompanying documentation does not include all residual risks associated with the device’.

Consistent process

Our structured interface enables rigorous reviews and live feedback.

An illustration showing a chat between a Scarlet customer and a customer assistant at Scarlet. The customer is asking for help with their risk estimates. An automatic notice tells the customer that,‘as a Notified Body, Scarlet is unable to offer consultation on how to complete your documentation.’ The customer assistant replys to the customer telling them that all the information required for their application can be found in the risk estimate input form.

Transparent approach

Every step of the process is designed with clarity and collaboration in mind.

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