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 outcome
•
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
