Assure: revenue, reputation, regulatory.

Attackers don't care about your SOPs. If your cyber and privacy risk management has gaps, they will exploit them.

What's included

Foundation, Model, and Operate plus:

  • Threat modeling and analysis covering patient safety, privacy, cybersecurity, and AI agent risks.
  • For 510(k), PMA, De Novo, HDE, clinical AI and devices already in the field under Section524B
  • Quantitative risk + exploitability
  • Cyber risk management plan
  • Prioritized, cost-effective countermeasure plan
  • FDA-Cyber ready package for pre or post-marketing submission.

14 FDA clearances. 0 rework requests on threat model submissions.

Foundation → Model → Operate → Assure

Pricing

$43K

Fixed outcome. Fixed price.

Q2 Capacity
10
total
7
committed
3
remaining

Engagement-led. No outsourcing.

Assure revenue, reputation, and regulatory compliance

Invest 30-minutes in your business.

Schedule a call
Stress-test your system

Assure combines our Foundation, Model, and Operate tiers into an ongoing program of cost-effective risk mitigation.

Assure includes everything you need for FDA pre-market or post-market submission packages.