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Generate Usability Report
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File Summary
Summary
HF Study Advisor
Step 1: Predicates & Research Sources
Select which sources the AI should use to inform user group selection. MAUDE, 510(k), and PubMed are free public APIs. Market Intelligence uses Tavily (requires API key in production).
Step 2: Device Types
We've pre-populated FDA device types to use when searching MAUDE, 510(k), and market sources. Toggle any off to exclude it, or type to add more from the FDA classification list.
Review & Generate
Review your inputs and run the AI analysis to generate FDA-compliant user groups.
What the AI will produce:
- User Groups with all 6 FDA-required factors, participant counts, and testable screener criteria
- Use Scenarios mapped to user groups with risk ratings and stress conditions
- FDA Signals from research sources highlighting critical considerations
- Regulatory Rationale grounded in FDA Human Factors guidance documents
- Study Design Notes with recommendations for session structure and simulation fidelity
Important Disclaimer
This AI-generated analysis is a starting point and must be reviewed by qualified human factors engineers. All user group selections, screener criteria, and regulatory rationale require validation before FDA submission. This tool does not constitute regulatory advice.
Starting analysis…
Analysis Results
Design Change Analyzer
FDA regulatory impact assessment
The Change
What changed, when you plan to submit, and who and what it touches.
From the project's original regulatory pathway.
What changed, why, and what problem it fixes.
FDA counts labeling, packaging and training as part of the user interface.
For example: easier to use, fewer steps, reduces errors, or easier than a competitor's device.
Steps added, removed or reordered. Changed feedback, timing, confirmations or navigation.
Tasks & Risk
Which tasks the change affects, and whether the risk documentation covers it.
Older devices and some exempt devices don't have a validation study on file.
A critical task is one where a use error could cause serious harm, including compromised care. Take this from your UFMEA. Not required when the change touches no part of the user interface.
Field Data
Complaints, MAUDE reports and adverse events behind the change.
User Testing Data
Results from testing with users, prior FDA feedback, and anything else relevant.
One row per distinct observation. Pick the task from the Step 2 list so the critical flag carries over. "Fixed by this change?" applies only to data from testing the previous design.
Regulatory Impact Assessment
Design change pathway analysis
Past Analyses
Recent design change assessments
Admin Panel
Manage Users
Agent Prompt Configuration
Configure AI agent prompts. System defaults apply to all tenants unless overridden per tenant.
Regulatory Reference Registry
Read-only registry of the standards, guidance, and data sources the AI tools cite. Curated via database migrations — each analysis records the registry snapshot it ran against.