SECTION 01
Executive Summary
Overall compliance readiness score, top 3 risks, top 3 strengths, and the deployment verdict — Deploy Ready, Conditional, or Not Ready.
SECTION 02
Model Overview
What the AI does, intended use case, regulatory environment, evaluation methodology, and model access method used.
SECTION 03
Stress Test Results
Results of 50+ structured test prompts across 8 categories — hallucination rate, edge cases, adversarial inputs, and performance consistency.
SECTION 04
Bias & Fairness Assessment
Performance across FDA-specified demographic groups — age, gender, ethnicity, and geography. Color-coded performance gap analysis.
SECTION 05
Regulatory Framework Mapping
Clause-by-clause table showing how the model maps to FDA 2025 AI Guidance, NIST AI RMF 1.0, ISO 14971, CMS requirements, and DoD principles.
SECTION 06
Expert Reviewer Findings
Independent clinical or domain expert assessment of flagged AI outputs. Licensed specialists provide judgment no automated tool can replace.
SECTION 07
Risk Register
Complete table of all identified risks rated High, Medium, or Low severity with recommended remediation actions for each.
SECTION 08
Remediation Roadmap
Step-by-step prioritized action plan with estimated effort and timeline. This section creates repeat business — clients fix issues and return for re-evaluation.
SECTION 09
ClearanceAI Assessment Statement
The formal conclusion with SHA-256 evidence anchor, compliance readiness score, conditions for deployment, and standard disclaimer. Suitable for regulatory submissions.