Feebris × Scarlet

Achieving MDR certification in just six months

How Feebris certified their life-changing SaMD to support critical NHS priorities

The Challenge

Feebris were facing a long, uncertain wait to get their pioneering AI medical device to market, delaying patient access and prohibiting health systems from adopting transformative technology that can alleviate capacity pressures

Customer Snapshot
  • High-growth, start-up SaMD manufacturer
  • Developing AI-powered solutions for precision healthcare at home
  • Seeking EU MDR certification for Class IIb AI medical device
Impact
  • Ensures clinical reliability of cardiorespiratory information captured at home, with 98% accuracy across studies
  • Helps provide a safe and effective alternative to hospital admission, with patients recovering at home

“We were facing a long and uncertain wait to get a truly ground-breaking device to market. Scarlet’s focus as a Notified Body on AI & SaMD meant we could release it in 
2024 and start changing lives for the better.”

Licy Prasad, Senior QARA Manager at Feebris

The Scarlet Process

Scarlet combines clinical & AI experts, a structured assessment process with regular actionable findings, and SaMD-friendly technical file submission — which led to a highly efficient time to market for Feebris.

the scarlet process demonstrating structured submission
How It Worked

To ensure no unnecessary delays, we:

  • Used Scarlet’s structured technical submission forms with automated checks to streamline Feebris’ application — avoiding unnecessary work
  • Deployed Scarlet’s expert assessors, who combine deep knowledge of clinical matters and AI medical devices, to efficiently understand Feebris’ product — avoiding needless back and forth
  • Ran Scarlet’s modular assessment process and set up regular rounds of findings for Feebris, coupled with clarification calls — avoiding wasted effort

The Results

Scarlet’s approach resulted in:

  • A six-month time to EU MDR certification
  • The release of PlethAI to market in 2024, in time to tackle critical NHS priorities such as winter pressures and the elective backlog
  • Allowing NHS patients to be at home with their families rather than taking up a hospital bed

“Our certification journey with Scarlet was streamlined and efficient. They are really responsive, and the fact they’re software & AI specialised made for such a smooth and effective assessment process. That drastically increased the impact we were able to have with
PlethAI.”

Licy Prasad, Senior QARA Manager at Feebris

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