Flok Health × Scarlet
14 weeks to get EU MDR certification of an AI physiotherapy device
“Scarlet have built a Notified Body for the AI world. The ability to release more rapid and frequent upgrades to our medical device ensures that our patients always have access to world-class care.”
Finn Stevenson
Co-founder & CEO, Flok Health
The challenge
Flok Health needed a Notified Body with AI expertise to efficiently certify their device and allow for frequent product updates
Customer snapshot
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Cambridge-based SaMD company that reduced waiting lists for back-pain treatment by 55% in first large-scale NHS deployment
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Developed an AI-powered approach that saved 856 hours of clinician time per month in one NHS Trust
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Seeking SaMD-specialised Notified Body for EU MDR certification to broaden product development, increase NHS access, and allow for efficient product iteration
The outcome
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EU MDR certification in 14 weeks
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Flok Health can now expand and efficiently iterate their ground-breaking product
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More patients across the NHS can benefit from Flok Health’s service, reducing waiting lists
“We want to release upgrades to our medical device twice a month. We can with Scarlet. No one else can deliver that.”
Finn Stevenson
Co-founder & CEO, Flok Health
