Step 01
AI Model Intake
Submit a clinical AI model for regulatory evaluation. RegOS structures intake data into a standardized, traceable record.
Step 02
Structured Validation
RegOS runs structured validation checks across five regulatory domains. Each check is traceable and reproducible.
Step 03
Risk Scoring
Automated risk assessment across regulatory dimensions, weighted by clinical impact and data quality.
Step 04
Regulatory Decision
RegOS generates a structured, defensible decision record based on the evaluation evidence.
Step 05
Evidence Package & Audit Trail
Every step is captured in a structured evidence package — reproducible, exportable, and submission-ready.