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
•
Cambridge-based SaMD company that reduced waiting lists for back-pain treatment by 55% in first large-scale NHS deployment
•
Developed an AI-powered approach that saved 856 hours of clinician time per month in one NHS Trust
•
Seeking SaMD-specialised Notified Body for EU MDR certification to broaden product development, increase NHS access, and allow for efficient product iteration
The Scarlet Process
Scarlet's SaMD expertise, use of clarification calls, and high-touch account management allowed Flok Health to get certified in 14 weeks
Scarlet’s approach resulted in:
•
EU MDR certification in 14 weeks
•
Flok Health can now expand and efficiently iterate their ground-breaking product
•
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
