Fixed Outcome. Fixed Price.

Choose an OpenCRO tier

Start with Foundation. Upgrade when your device, AI, or regulatory requirements change.

Foundation

$3k/year

Outcome: Understand your cyber and privacy exposure.

  • Understand your exposure
  • Threat story (how your device, customer and patients actually get attacked)
  • Cyber and privacy SOPs
  • 4x/year advisory calls
  • Support: Email
  • Prioritized, cost-effective countermeasure plan
  • Top risk threats after mitigation
  • Architecture review
  • Threat model and analysis
  • Quarterly audits & threat model updates
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Model

$9k/year

Outcome: Risk analysis of your AI-enabled medical device.

  • Understand your exposure
  • Threat story (how your device, customer and patients actually get attacked)
  • Cyber and privacy SOPs
  • 4x/year advisory calls
  • Support: Email + Slack
  • Prioritized, cost-effective countermeasure plan
  • Top risk threats after mitigation
  • Architecture review
  • Threat model and analysis
  • Quarterly audits & threat model updates
Get Started

Operate

$12k/year

Outcome: Adapt as attackers, AI and guidance evolve.

  • Understand your exposure
  • Threat story (how your device, customer and patients actually get attacked)
  • Cyber and privacy SOPs
  • 4x/year advisory calls
  • Support: Email + Slack
  • Prioritized, cost-effective countermeasure plan
  • Top risk threats after mitigation
  • Architecture review
  • Threat model and analysis
  • Quarterly audits & threat model updates
Get Started

Assure

$43k/year

Outcome: Clear FDA, govern Total Product Life Cycle.

  • Understand your exposure
  • Threat story (how your device, customer and patients actually get attacked)
  • Cyber and privacy SOPs
  • 4x/year advisory calls
  • Support: Email + Slack + WhatsApp
  • Prioritized, cost-effective countermeasure plan
  • Top risk threats after mitigation
  • Architecture review
  • Threat model and analysis
  • Quarterly audits & threat model updates
  • FDA-Cyber submission documentation package
  • Govern TPLC: Clear FDA, and sustain compliance with continuous risk review.
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All tiers include our core cyber and privacy risk assessment. The Assure tier adds Total Product Life Cycle (TPLC) governance with FDA submission documentation.