Fixed Outcome. Fixed Price.
Choose an OpenCRO tier
Start with Foundation. Upgrade when your device, AI, or regulatory requirements change.
Foundation
$3k/year
Understand your exposure to cyber and privacy risk
- Understand your exposure
- Threat story (how your device, customer and patients actually get attacked)
- Cyber and privacy SOPs
- 4x/year advisory calls
- Prioritized, cost-effective countermeasure plan
- Top risk threats after mitigation
- Architecture review
- Threat model and analysis
- Quarterly audits & threat model updates
Model
$9k/year
Prioritized cost-effective countermeasure plan
- Understand your exposure
- Threat story (how your device, customer and patients actually get attacked)
- Cyber and privacy SOPs
- 4x/year advisory calls
- Prioritized, cost-effective countermeasure plan
- Top risk threats after mitigation
- Architecture review
- Threat model and analysis
- Quarterly audits & threat model updates
Operate
$12k/year
Update risk 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
- Prioritized, cost-effective countermeasure plan
- Top risk threats after mitigation
- Architecture review
- Threat model and analysis
- Quarterly audits & threat model updates
Assure
$43k/year
Govern TPLC (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
- Prioritized, cost-effective countermeasure plan
- Top risk threats after mitigation
- Architecture review
- Threat model and analysis
- Quarterly audits & threat model updates
- Govern TPLC: Launch your AI, clear FDA, and scale with continuous risk review.
- FDA-Cyber submission documentation package
All tiers include our core cyber and privacy risk assessment. The Assure tier adds Total Product Life Cycle (TPLC) governance with FDA submission documentation.