Risk Analysis for AI-enabled medical devices
How much of your value is at risk?
Most CEOs find out too late.
OpenCRO identifies the cyber and privacy threats most likely to impact revenue, regulatory approval, reputation, and patients.
Fixed outcome. Fixed price.
14 FDA clearances. WHO Europe Digital Health cyber and privacy guidance.
Your science works. Your value exposed.
• Hospital procurement is delayed
• An FDA reviewer asks questions you cannot answer
• A bug becomes a patient safety issue
• A strategic partner finds a vulnerability during diligence
• A privacy incident kills a deal
Clinical AI raises the bar.
• Training data
• Inference data
• AI agents
• Third-party models
• Open source libraries
• Update paths and SBOM gaps that delay clearance
Every new dependency expands your attack surface.
Business Threat Modeling.
Danny Lieberman runs a 2-hour workshop with your team. You tell stories — how your device, patients, customers, and business could be attacked. You write them on cards, sharpies only.
OpenCRO agents scan the cards and build your threat database. More agents run the analysis. Minutes later: a complete threat model, with exploitability, value at risk and a countermeasure plan.
Human-in-the-loop, machine-speed. You'll know exactly what to fix first.
Here's what that looks like in practice:
Risk-driven software in a post AI, post-privacy era
Here's a free download of the Business Threat Modeling Guide. AI has changed how we code but the fundamentals of software engineering remain the same—understand what risks really count for your business and mitigate operational threats with good software security.
Your attackers, customers, and competitors are moving faster than you.
Invest 30 minutes. After the call we'll send you a preliminary threat assessment. We'll find out if you're a good fit for OpenCRO.