Regulatory Mapping
Populate your organization’s approved regulatory templates with real pipeline evidence from AESOP, under a human review gate.
The concept
Regulated environments require documented evidence that AI systems do what they were specified to do. Most platforms generate regulatory documents from scratch. AESOP takes a different route: you bring your own approved templates — ISO 13485 validation protocols, change-control forms, risk registers, audit SOPs. AESOP reads them, identifies the fields that need data, maps them to evidence your pipeline already generated, and produces completed documents ready for QMS filing. AESOP is evidence infrastructure, not a regulatory authority.
How to access it
templates
pipeline
Regulatory Mapping
Evidence mapping
Analysis
Review Gate
Documents
Data sources
| Template field | Evidence source — from AESOP |
|---|---|
| Intended use | State Change Hypothesis (Build) |
| Test protocol | Eval scenario library |
| Test evidence | Certification report + scores |
| Risk identification | Safety + Bias agent findings |
| Risk mitigation | Repair-cycle output |
| Residual risk | Certification level (Platinum / Gold / Silver / Bronze) |
| Change description | Version diff from Repair |
| Change rationale | Repair change summary |
| Pre/post evidence | Score delta across cycles |
| Monitoring plan | Maintenance plan from Launch Package |
The process
templates
templates
mappings
documents
file
Regulatory Mapping does not certify agents for regulated use. That decision belongs to your quality team. AESOP produces the evidence that feeds your QMS.