Why AI audits exist now

AI models are moving into regulated products in medical devices and financial services. Reviewers working under frameworks such as the EU AI Act (for high-risk systems) and FDA's evolving expectations for AI/ML-enabled devices don't ask, "Is your model accurate?" They ask, "Show me."

Reviewers don't ask "is your model accurate?" They ask "show me."

They want evidence: what data trained the model, how performance was validated, where it can fail, and what happens when it does. An audit builds that evidence package before the reviewer asks for it.

Anatomy of a ClearanceAI audit

Every engagement runs in layers.

Layer Price What it is
LAYER 0 Free The diagnostic. We scope what the model does, where it touches regulated decisions, and which standards apply. The output is a gap map showing exactly where your evidence is thin.
LAYER 1 $3,500 The structured audit. Documentation review, data provenance, and performance evidence, evaluated against the requirements that apply to your product.
LAYER 2 $8,500–$25,000 The adversarial deep-dive. Using our proprietary 9P/2G framework, the model is stress-tested the way a skeptical reviewer, or an adversary, would probe it.

See where your evidence is thin

The Layer 0 diagnostic is free. Answer a short set of questions about your model and get a gap map showing where your evidence needs work.

Inside a sample finding

Every finding in a ClearanceAI report follows the same structure: finding ID, severity rating, the requirement it traces to, evidence observed, the gap, recommended remediation, and re-test criteria. Here is what one looks like. This is an illustrative example, not a real client finding.

// Finding A-04 (ILLUSTRATIVE)
Subgroup performance not characterized
Severity
Major
Requirement
Validation must reflect the intended patient population.
Evidence observed
Validation reports overall AUC of 0.94 with no stratified results for the over-75 subgroup, which represents ~40% of intended users.
Gap
No evidence the model performs equivalently in the largest user subgroup.
Remediation
Stratified validation on the over-75 cohort; acceptance criteria agreed before re-test.
Re-test
Repeat after remediation with pre-registered subgroup thresholds.
ILLUSTRATIVE EXAMPLE — NOT A REAL CLIENT FINDING

The format matters because a reviewer can trace each finding to a requirement, see the evidence behind it, and verify the fix. There is no narrative to interpret, and nothing is left to hand-waving.

What you walk away with

The audit report has three parts:


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By NR Koka, Founder, ClearanceAI
20+ years as a Quality Engineer in MedTech (Abiomed, Baxter, GE Healthcare, and others), with deep experience in EU MDR transitions and FDA 21 CFR 820 compliance. NR previously built MedDeviceAudit, an AI-powered compliance-auditing platform for Class II medical devices.

Beta offer: 5 free audit reports

We're currently offering 5 free audit reports to beta testers. You share your project details, we deliver a full audit, and you tell us what to improve. Start with the free Layer 0 diagnostic to see where your evidence gaps are.

This article is general information. It is not legal or regulatory advice and does not guarantee any regulatory outcome.