Certify your software medical device without unnecessary delays.

Get your life-changing technology to the people who need it, with Europe’s only Notified Body specialised in software and AI.

Process

Medical device certification built for software and AI.

Software and AI are the future of medicine. We're helping to pull the future into today with a specialised certification process for SaMD manufacturers. This means you can safely, predictably, and continuously get the best technology to market.

Mission

Our mission is to hasten the transition to universally accessible healthcare.

We strive to achieve our mission by enabling our customers to deliver on theirs.

Designations

We are accredited and regulated by:

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

Need to certify a software medical device?

Schedule a call or demo, or simply ask for more information about Scarlet's process and platform.