Augmedit × Scarlet
EU MDR certification for multiple Augmented Reality neurosurgery devices
“Working with Scarlet actually led to us creating higher quality SaMD. Their expert feedback meant we refined our work and built better versions of our products.”
Claartje Ypma
Co-founder & CEO, Augmedit
The Challenge
Augmedit needed a Notified Body with AI expertise to understand and certify their Augmented Reality (AR) & Extended Reality (XR) devices
Customer Snapshot
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Netherlands-based start-up bringing AI-driven AR SaMD to improve real-time anatomical understanding and surgical outcomes
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Developed a suite of solutions addressing neurosurgery navigation and planning challenges
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Looking for a Notified Body with deep knowledge of AI devices to gain EU MDR & ISO 13485 certification and enable iterative product improvements
The Scarlet Process
Scarlet’s AI expertise and high-touch account management helped Augmedit to get the very best versions of their technology to doctors
Scarlet’s approach resulted in:
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EU MDR certification for three cutting-edge devices
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Augmedit can now expand and efficiently iterate their ground-breaking technology
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Products in use with first patients in the Dutch healthcare system: EVD (external ventricular drain) procedures performed using Augmedit’s AR with a patient-specific hologram of the brain
“It’s great to work with a Notified Body that truly understands AI.”
Claartje Ypma
Co-founder & CEO, Augmedit
