You're a CEO, not a Chief Risk Officer. The FDA and hospital procurement teams expect you to be both.

The Offer

You need an FDA cybersecurity threat analysis to clear your device. We build it to the FDA Cybersecurity Premarket Guidance (Feb 2026). Fixed price. Fixed time. Fixed outcome.

You receive:

Complete FDA-ready threat model
Documented threat analysis
Exploitability and residual risk computation
Prioritized cybersecurity countermeasure plan
Executive summary
Submission-ready report

$43,000 — one indication, one device.

Stay Current

Your threat model reflects the threat landscape at submission. That landscape changes daily.
Ransomware variants evolve. New supply-chain vulnerabilities emerge. Hospital procurement teams are asking harder questions. What the FDA cleared today may not satisfy a hospital privacy review in Europe tomorrow.

The OpenCRO Stay Current program keeps your device ahead of the curve:
Quarterly security audit against current exploit intelligence and regulatory guidance in your markets
Threat model updated to reflect new attack vectors
Vulnerability gap analysis against recent incidents
Executive briefing your team can act on

Annual Retainer $6,250/year
Available to OpenCRO threat model clients only.

Why OpenCRO?

Specialist with deep business, entrepreneurship, clinical data, engineering and analytical expertise.

Cybersecurity advisor to WHO Europe - I wrote their guidance for digital health.

I led cybersecurity and privacy for 42 MedTech companies through FDA submissions and clinical trials. 14 FDA clearances. De Novo world record — Theranica, 9 months from first patient to clearance. Zero rework requests on threat model submissions.

Why Now?

Ransomware and supply-chain attacks shape how hospitals evaluate device vendors. The FDA moves decisively — guidance is more explicit, documentation expectations are higher, review questions are deeper and more technical.

The 2026 guidance requires discipline and depth that generalists can't deliver. Serious teams respond with precision.