Skin Analytics × Scarlet
Bringing a Class III AI dermatology device to the European market
“If you're looking for a Notified Body that understands SaMD then Scarlet is the one to work with.”
James Hamlyn
QA/RA Director, Skin Analytics
The Challenge
Skin Analytics were looking at a long wait to get their proven skin-cancer-detection product DERM to the European market, and were seeking a Notified Body with AI expertise
Customer Snapshot
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Growing start-up that developed a transformational skin-lesion-analysis SaMD that had already been widely deployed in the NHS, looking to expand internationally
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99.8% accurate in ruling out high-risk skin cancer, compared to face-to-face dermatologist evaluations of 98.9%
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Seeking swift EU MDR certification from a Notified Body that understands AI
The Scarlet Process
Scarlet's AI expertise, clear assessment process, and SaMD-friendly technical-file submission led to a highly efficient time to certification for Skin Analytics
Scarlet’s approach resulted in:
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EU MDR certification significantly ahead of the expected timeline
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DERM became the first AI approved to make clinical decisions autonomously in the cancer space
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Skin Analytics’ proven technology is now available, ahead of schedule, to patients and healthcare systems across the European market
“We were looking at a long and unclear path to certification. Scarlet’s expertise in AI & software changed that. They were able to efficiently understand a highly novel AI product. That meant we got to market far quicker than originally expected.”
James Hamlyn
QA/RA Director, Skin Analytics
