Real-world MedTech cybersecurity
Cleared by FDA.
Survives the
real world.
Yesterday you designed for patients.
Today you design for survival.
42 companies • 14 clearances • 0 rework
Two types of FDA submissions
FDA can tell the difference in minutes
Documentation-driven
- Controls listed
- Vague risk
- Reactive
Model-driven
- Computed residual risk
- Defensible
- Confident
Where submissions break
- Architecture fixed too early
- Interfaces not modeled
- Countermeasures not tied to exploitability
- No evidence chain
You don't see this until FDA pushes – or production breaks
This is how risk is modeled
End-to-end threat model
SYSTEM
↓
ASSETS
↓
THREATS
↓
COUNTERMEASURES
↓
EXPLOITABILITY
↓
RESIDUAL RISK
System architecture → quantified residual risk
This is what FDA expects to see.
If you can't show this, your submission will stall.
The OpenCRO system
Foundation
$3K
Model
$6K
Operate
$9K/year
Clear
$43K
Submitting in 6–9 months?
Capacity is limited
We take on a limited number of submissions per quarter.
Q2 Capacity
10
total
7
committed
3
remaining
Each engagement is led directly. We don't outsource the thinking
Who this is for
- Teams preparing for FDA submission
- Any cyber device under section 524B(c)
- AI for clinical delivery, diagnosis, monitoring or treatment decisions
- Teams that want outcomes not billable hours
- Teams that want defensible answers
42 companies have already gone through this system
Fixed outcome. Fixed price.