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"Europe's only Notified Body specialising in software and AI medical device certification"
Scarlet certifies software and AI medical devices for manufacturers across Europe and the UK. As the only Notified Body specialised in this field, Scarlet enables healthcare innovators to bring life-changing technology to market safely, predictably, and continuously. The company addresses complex regulatory requirements without unnecessary delays. The single biggest blocker to innovation in healthcare is the time it takes to safely bring new products to market. Scarlet solves this with a certification process built specifically for software as a medical device. Patients gain faster access to the latest AI and software technologies that can transform their care, while manufacturers maintain the agility to update and improve their products.
35
Team Members
2021
Founded
Consulting
Sector
Hybrid
Work Environment
A world where patients everywhere have immediate access to the latest software and AI medical technologies, enabling universally accessible healthcare that continuously improves and adapts to serve every person who needs it.
Hasten the transition to universally accessible healthcare by enabling medical device manufacturers to safely and efficiently certify software and AI technologies.