BrightHeart × Scarlet
EU MDR & ISO 13485 certification for two AI-powered prenatal ultrasound devices
“Scarlet always communicate the right information to us at the right time so that we know what's happening. Their team is so dedicated.”
Saramony Lebasnier
Director of QARA, BrightHeart
The Challenge
BrightHeart needed a Notified Body that could move quickly and understand AI to meet their MDR timelines
Customer Snapshot
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French startup working on AI image-analysis support for prenatal ultrasound
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Developing devices that help sonographers with earlier detection of congenital heart defects, allowing improved outcomes for babies and their families
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Seeking a Notified Body for EU MDR & ISO 13485 certification, plus the ability to handle ever-improving AI models
The outcome
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EU MDR & ISO 13485 certification for two Class IIa AI medical devices
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BrightHeart now positioned to sell their FDA-cleared platform across Europe as well
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The BrightHeart team can update the platform frequently so their customers, and patients, always get the latest version of their software
“Obtaining CE marking is a critical step towards achieving our mission and Scarlet were a huge part of that. They were such a pleasure to work with.”
Saramony Lebasnier
Director of QARA, BrightHeart
