Flok Health × Scarlet
Under 4 months to get EU MDR certification of an AI medical device
How Flok Health & Scarlet got an innovative SaMD certified and set up to deliver autonomous healthcare in the NHS
“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 software expertise to efficiently certify their device and allow for frequent product updates
Customer Snapshot
- Cambridge-based SaMD start-up addressing long waiting lists for musculoskeletal physiotherapy
- Developed an AI-powered approach being used in the NHS
- Seeking SaMD-specialised Notified Body for EU MDR certification to broaden product development, increase NHS access, and allow for efficient product iteration
Product Impact
- Reduced waiting lists for back-pain treatment by 55% in first large-scale NHS deployment
- Saved 856 hours of clinician time per month in one NHS Trust
The Scarlet Process
Scarlet's software expertise, use of clarification calls, and high-touch account management allowed Flok Health to get certified in four months
How It Worked
To ensure an efficient process, we:
- Used Scarlet’s AI specialists to efficiently understand Flok Health’s product — avoiding needless back and forth
- Used expert clarification calls to convey regulatory requirements — avoiding wasted effort
- Maintained regular contact and responsive support for Flok Health — avoiding uncertainty over timelines and planning
The Results
Scarlet’s approach resulted in:
- EU MDR certification in under four months
- 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
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