Scarlet certifies software medical devices. We’re Europe's only Notified Body specialized in software and AI, and have crafted a certification process that is built for software and is thus significantly more efficient. This is how we deliver on our mission to hasten the world’s transition to accessible healthcare: by enabling manufacturers to release their medical software and AI to those who need it without unnecessary delays. We are designated as a UK Approved Body by the MHRA and an EU Notified Body by the Dutch Ministry of Health and the European Commission.