Revenue assurance for MedTech.

Identify where your revenue breaks: regulatory, cyber and security risk, clinical efficacy, safety, integration, interfaces, buyers.

Fixed price. Fixed outcome.

14 FDA clearances.
Author, WHO Europe cybersecurity guidance for Digital Health.

SYSTEM ASSETS THREATS EXPLOITABILITY COUNTERMEASURES RESIDUAL RISK

Revenue breaks in two ways

Know which type before your deal stalls

Unexamined

  • Features listed
  • Risks hidden
  • Failures on launch

Architected

  • Risks computed
  • Defensible
  • Revenue assured

Where revenue breaks

  • Architecture fixed too early
  • Interfaces not secured
  • Risk mitigation not prioritized
  • No go-to-market readiness

You don't see this until customer deployment or regulatory review

This is how we assure your revenue

System to residual risk mapping

SYSTEM
ASSETS
THREATS
COUNTERMEASURES
EXPLOITABILITY
RESIDUAL RISK

System architecture → computed residual risk

Identifies what breaks your revenue, then priorities the fixes.

The OpenCRO system

Foundation

$3K

Model

$6K

Operate

$9K/year

Clear

$43K

Submitting in 6–9 months?

Submitting without this costs more.

Clear – $43K

Fixed outcome. Fixed price.

Get FDA-ready

Not submitting yet?

Model – $6K

Fixed outcome. Fixed price.

Where revenue breaks

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

  • Devices generating revenue under compliance pressure
  • AI for clinical delivery, diagnosis, monitoring or treatment decisions
  • CEOs that want outcomes not billable hours

42 companies have already gone through this system

Fixed outcome. Fixed price.

Identify where your revenue breaks

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