The problem
AI medical device makers wait 12-18 months for certification and months more for each update
What they do
Government-designated certification body for AI and software medical devices (EU, UK, FDA)
Traction Team up ~60% in a year; customers include Flo Health, DeepHealth, NHS England, Heidi Health
Hiring trend
- Open roles
- 16
- Ops roles
- 2
- Headcount
- ~100
Headcount ~99, up ~60% in 12 mo (LinkedIn data, est.); 14 open roles in London, NYC, remote
Hiring in
- UK - London
- US - New York City
- Sweden - Stockholm
- Remote (Europe)
- Remote (US)
Glassdoor
5.0 ★ 3 reviews ↗Funding
- Last round
- $50M
- Stage
- Series B
- Date
- Oct 2026
Led by Headline
- Hiring+1.516 open roles on the live job board (10–29 roles = +1.5)
- Funding recency+1.5Series B · $50M, Oct 2026 (this month): 6 months or less = +1.5
- Traction+1.5Strong growth: Team up ~60% in a year; customers include Flo Health, DeepHealth, NHS England, Heidi Health
- Red flags0None found in the last 24 months
- Total4.51.5 + 1.5 + 1.5 − 0 = 4.5 → Race (4.25–4.74)
Distance (Half) is a separate read on how long the lead can last. It doesn't change the score.
Distance
Half · edge: hard to leave
Legal designation as a certifier took three years to win and is hard to copy, and it is the only one of ~52 EU bodies focused on AI.
Sources: Tech.eu, Oct 2026: only AI/software specialist among ~52 EU notified bodies; EU, MHRA and FDA designations; customer list ↗ · Notion Capital, Oct 2026: designations as springboard; MDSAP, ISO 13485/27001/42001 ↗ · Headline, Oct 2026: same legal standing as century-old incumbents; FDA third-party reviewer ↗
Last checked Oct 25, 2026