Proving Patient Safety at the Speed of Code.
Replace expensive, manual recruitment with Synthetic Clinical Agents. Run thousands of Formative usability tests overnight and de-risk your FDA submission.
Your Product is Agile.
Your Compliance is Waterfall.
The mandate is clear: every medical device must prove it is safe. But the reality is a logistical nightmare. Recruiting specialized clinicians takes weeks, costs thousands, and creates a "blind spot" in your development cycle.
The Recruitment Trap
Finding an Interventional Radiologist for a 1-hour test takes 3 weeks and $2,000.
The 'One-Shot' Risk
Failing Summative Validation delays launch by 6-12 months. Cost: $10M+.
The Bias Factor
Internal 'hallway testing' misses the errors a stressed, naive user will make.
The Always-On Patient Safety Sandbox
We provide a library of Synthetic Clinical Agents that interact with your software interface exactly like human users—but at infinite scale.
Cognitive Simulation
Our agents have memory limits. They get distracted. They forget instructions. We simulate human error, not just human intelligence.
Motor Impairment
Test for the tremor. Our agents simulate Parkinson's and neuropathy using Fitts' Law algorithms to inject motor noise into cursor paths.
Visual Processing
The agents don't just read code; they 'see' the pixels. They identify contrast issues, small buttons, and confusing layouts instantly.
Traceability Built for ISO 14971
Every simulated click, hesitation, and error is logged. Sigil AI automatically flags "Hazard-Related Use Scenarios" and generates the documentation needed for your Risk Management File.
- ✓ USE_ERROR_LOGS generated automatically
- ✓ ISO 14971 Risk Linking
- ✓ Formative Study Protocols (Auto-Drafted)
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Stop flying blind into your FDA submission.
Start your first synthetic Formative study today.