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.
Misson
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:
Need to certify a software medical device?
Schedule a call or demo, or simply ask for more information about Scarlet's process and platform.