BETA EVALUATIONS OPEN — NDA + MSA REQUIRED

AI Cleared
for Deployment.

Before your AI touches a patient, a loan decision, or a defense system — it needs independent validation. ClearanceAI is the Ernst & Young of AI model evaluation for regulated industries.

Take Free Assessment → Request Evaluation
No client data used for training NDA required before access SHA-256 anchored reports
// CAAI-2026-SAMPLE · NOVADX AI CONDITIONAL
79
/ 100
Compliance Readiness Score
⚠ Conditional Deploy
Regulatory Alignment
88
Bias & Fairness
62
Independent Evidence
91
Post-Deploy Monitoring
45
AI Architecture Risk
80
How It Works

Three layers.
One verdict.

ClearanceAI combines automated testing, credentialed expert review, and regulatory framework mapping into a single formal assessment report your regulators, investors, and enterprise clients can trust.

0
FREE FOREVER
Readiness Diagnostic
Free · No signup required · 5 minutes
Answer 15 plain-language questions about your AI model and get an instant compliance readiness score with a clause-by-clause gap analysis across 21 regulatory requirements.
  • 5-dimension compliance readiness score
  • Clause-by-clause gap table — FDA, NIST, ISO 42001, IEC 62304, ISO 14971, EU AI Act, CMS
  • Critical vs moderate gap identification
  • Layer 1 or Layer 2 recommendation
  • Instant results — no waiting
Start Free Assessment →
1
AUTOMATED EVALUATION
Evaluation Engine
$3,500 one-time · or $1,500/month subscription
Our automated evaluation engine runs 30-50 structured test prompts against your AI model and produces a formal compliance report mapped to named regulatory clauses — without human review.
  • 30-50 structured test prompts
  • Full regulatory clause mapping
  • Hallucination and edge case testing
  • Demographic bias assessment
  • Remediation roadmap with prioritized actions
  • Monthly subscription for ongoing monitoring
Request Layer 1 →
2
INDEPENDENT ASSESSMENT
Expert-Reviewed Report
$8,500 – $25,000 per engagement
Everything in Layer 1 plus credentialed expert human review of flagged items, a formal 9-section assessment report, and the ClearanceAI Readiness Verified designation if your AI scores 85 or above.
  • Full Layer 1 automated evaluation
  • Credentialed expert reviewer — RAC, FRAPS, ISO Lead Auditor
  • Formal 9-section compliance assessment report
  • Expert Reviewer Findings — independent written assessment
  • SHA-256 anchored Assessment Statement
  • ClearanceAI Readiness Verified if score ≥85
  • 12-month validity with monthly smoke tests
Request Layer 2 →
Layer 0 — Free Diagnostic → Layer 1 — Automated Evaluation ($3,500) → Layer 2 — Independent Assessment ($8,500–$25,000)
Regulatory Frameworks

No government logos.
Just deep expertise.

ClearanceAI evaluates your AI against the specific regulatory frameworks your industry requires — not generic benchmarks.

🏥
FDA 2025 AI Guidance (Draft) + PCCP Final
§ 5.1 · § 5.3 · § 5.4 · § 7.1 · PCCP § 4.1-4.3
Total Product Lifecycle approach for AI-enabled medical devices. PCCP Final Guidance is binding — August 2025.
HEALTHCARE
📊
NIST AI RMF 1.0
GOVERN · MAP · MEASURE · MANAGE
The most comprehensive voluntary AI risk management framework — applicable across all regulated sectors.
ALL SECTORS
🌐
ISO 42001:2023
Clause 6.1 · Clause 8.4 · Clause 9.1
The world's first AI Management System standard. Notified Bodies are already asking about it in MDR audits ahead of August 2027.
ALL SECTORS
💊
ISO 14971:2019
§ 4.4 · § 5.4 · § 7.1
Medical device risk management — extended for AI-specific hazards including hallucination, drift, and demographic bias.
HEALTHCARE
💻
IEC 62304:2006
§ 5.2 · § 8.1 · § 8.1.2
Medical device software lifecycle — including SOUP identification and anomaly list requirements for third-party AI components.
HEALTHCARE
🏦
SR 26-2 Model Risk
Materiality · Validation · Monitoring
Replaced SR 11-7 on April 17, 2026. Governs AI model risk for banks — and for MedTech AI touching reimbursement and prior authorization.
FINANCE
🇪🇺
EU AI Act
Article 9 · Article 10 · Article 14
High-risk AI system requirements. Key deadlines: December 2, 2027 (Annex III) and August 2, 2028 (Annex I).
GLOBAL
🏥
CMS AI Requirements
Non-Discrimination · Prior Auth AI
Equal AI performance across all patient demographic groups — mandatory for Medicare and Medicaid AI systems.
HEALTHCARE
🛡️
DoD AI Ethics Principles
CDAO Framework · Responsible AI
Department of Defense AI governance requirements for defense and government AI procurement.
DEFENSE
Industries We Serve

Every regulated AI
needs clearance.

If a regulator governs it and AI powers it, ClearanceAI evaluates it.

🏥
Healthcare AI
FDA 2025 AI Guidance (Draft) PCCP Final CMS ISO 14971 IEC 62304 HIPAA
SaMD, clinical decision support, diagnostic imaging AI, prior authorization AI, and revenue cycle AI. Our primary focus — with credentialed expert reviewers holding RAC, FRAPS, and ISO 42001 Lead Auditor designations.
🏦
Financial Services AI
SR 26-2 OCC Guidance CFPB AI Rules EU AI Act NIST AI RMF
Credit decisioning AI, model risk management, fraud detection, and algorithmic trading systems. SR 26-2 replaced SR 11-7 in April 2026 — most vendors have not updated their documentation.
🛡️
Defense & Government AI
DoD AI Ethics CDAO Framework NIST AI RMF FedRAMP CMMC
Defense procurement AI, intelligence analysis systems, and government decision-support AI. Independent third-party evaluation is increasingly required before contract award.
⚡
Energy & Infrastructure AI
NERC CIP FERC Guidance NIST AI RMF ISO 42001
Grid optimization AI, predictive maintenance systems, and critical infrastructure decision-support AI evaluated against NERC CIP and FERC guidance.
⚖️
Legal & Compliance AI
State Bar Requirements Court AI Rules NIST AI RMF ISO 42001
Legal research AI, contract analysis systems, and compliance monitoring AI evaluated against emerging bar and court AI governance requirements.
✈️
Aviation & Transport AI
FAA AI Guidance NHTSA Rules NIST AI RMF ISO 42001
Aviation safety AI, autonomous vehicle decision systems, and transportation infrastructure AI evaluated against FAA and NHTSA emerging AI frameworks.
Pricing

Transparent pricing.
No hidden fees.

Start free. Scale when you are ready. Every tier includes the same rigorous methodology — the difference is depth of expert review and report formality.

Layer 0
Readiness Diagnostic
Free forever
15-question assessment with clause-by-clause gap analysis. Instant results, no signup required.
  • 5-dimension compliance score
  • 21-clause gap analysis
  • Layer 1 or Layer 2 recommendation
  • Instant results
Start Free Assessment
Layer 1
Automated Evaluation
$3,500 one-time
Full automated evaluation engine with formal compliance report. Or subscribe for ongoing monitoring.
  • 30-50 structured test prompts
  • Full regulatory clause mapping
  • Bias and hallucination testing
  • Prioritized remediation roadmap
  • Monthly subscription: $1,500/month
Request Layer 1
Layer 2
Independent Assessment
$8,500 – $25,000
Full Layer 1 plus credentialed expert review and formal 9-section report. Tiered by device class and company size.
  • Everything in Layer 1
  • Credentialed expert reviewer sign-off
  • Formal 9-section assessment report
  • SHA-256 anchored Assessment Statement
  • ClearanceAI Readiness Verified if ≥85
  • 12-month validity
Request Layer 2
// Pricing tiered by company size and device risk class — Class II vs Class III. Contact us for enterprise and consultant partner pricing.
The Evaluation Report

Your AI's independent
audit trail.

Every ClearanceAI Evaluation Report gives you documented due diligence — the evidence your hospital, bank, or government client needs before signing a contract.

01 Executive Summary COMPLETE
02 Model Overview COMPLETE
03 Stress Test Results FLAGGED
04 Bias & Fairness Assessment REVIEW
05 Regulatory Framework Mapping COMPLETE
06 Expert Reviewer Findings IN REVIEW
07 Risk Register COMPLETE
08 Remediation Roadmap COMPLETE
09 Assessment Statement PENDING
View Full Sample Report →
// CAAI-2026-0001 · NOVADX AI · JUNE 2026 DEPLOY READY
87
/ 100
Compliance Readiness Score
✓ Deploy Ready
ClearanceAI Readiness Verified — Independent evaluation record, not a regulatory certification or approval. Valid 12 months subject to monthly smoke test.
FDA 2025 AI Guidance (Draft) PCCP Final Guidance ISO 14971 IEC 62304 NIST AI RMF 1.0 CMS Requirements
SHA-256 ANCHORED · TIMESTAMPED AT DELIVERY
VALID 12 MONTHS · SUBJECT TO MONTHLY SMOKE TEST
Get Started

Your AI needs clearance
before it ships.

Start with the free 5-minute assessment and see your compliance readiness score instantly. No signup required.

Take Free Assessment → Request Evaluation View Sample Report
// Beta evaluations open · NDA + MSA required before access · First evaluation free for qualified clients