Independent AI readiness assessments for regulated markets

Hospitals and banks ask AI vendors for documented evidence. ClearanceAI reviews your AI system and its documentation, finds the gaps, and gives you findings you can use in buyer review.

Take the free readiness diagnostic See a sample report

A scope-limited review of your evidence. It is not a certification, a regulatory approval or a guarantee of how your AI will perform.

AI Readiness AssessmentSample, redacted

Executive summary
Model overview
Stress test results
Bias assessment
Regulatory framework mapping
Expert reviewer findings
Risk register
Remediation roadmap
Assessment statement

Illustration of the report structure. Not a real client.

Buyers ask for evidence, and they ask early

Strong AI products stall in procurement when the answers are scattered, inconsistent or never written down.

Validation: What evidence supports your performance claims, and on which populations?
Data handling: How is our data stored and used, and who else can reach it?
Third parties: Which outside models and services does your system depend on?
Governance: Who is accountable for monitoring, change control and incidents?

Start free. Go as deep as the buyer requires.

Each layer adds depth of review. You can stop after any of them.

Layer 0, free

Readiness diagnostic

A short self-assessment that returns a readiness score across five dimensions and a gap view against the requirements that apply to your product.

Start the diagnostic

Layer 1

Automated evaluation

Structured test prompts run against your AI, including bias and hallucination checks. Findings are mapped to the relevant regulatory and standards clauses, with a prioritized remediation roadmap.

Request Layer 1

Layer 2

Independent assessment

Adds review by credentialed domain experts, a formal written report and an Assessment Statement. When the defined criteria are met, the result can carry the Readiness Verified designation.

Request Layer 2

What you receive

A structured readiness assessment and score
Documented findings and evidence gaps
Risk and control observations

Prioritized remediation recommendations
An executive summary for internal and customer review
Readiness Verified designation, when criteria are met

What Readiness Verified means

We use Readiness Verified on purpose, and not “Certified”. It records that a defined assessment was completed against specified criteria, using the evidence available within the agreed scope.

It is

An independent, scope-limited evidence review
A documented record you can share with buyers
Valid for 12 months, with monthly smoke tests

It is not

A safety certification or regulatory approval
A guarantee of accuracy, performance or freedom from malfunction
Something hospitals, banks or regulators must accept

Scope and liability

ClearanceAI’s Readiness Verified designation reflects an independent, scope-limited assessment of specified criteria and available evidence at the time of review. It is not a product safety certification, regulatory approval, or warranty of performance, reliability, or freedom from malfunction. Third parties may not rely on the assessment or designation without a separate written agreement with ClearanceAI.

Who stands behind the assessments

Assessments are led by regulatory compliance practitioners, with credentialed expert review on Layer 2.

NR Koka

Founder and reviewer

20+ years in medical device validation, Quality/Regulatory, including GE Healthcare, Baxter and Johnson & Johnson. FDA 21 CFR 820, ISO 13485, IEC 62304, ISO 14971 and NIST AI RMF.

James W. Monroe

Lead Expert Reviewer

FRAPS, RAC, CQA and ISO 13485 Lead Auditor. Provides the credentialed regulatory sign-off on Layer 2 assessments.

Rajeev Yadav, PhD

AI Regulatory Advisor

Advises on EU MDR, ISO/IEC 42001 and AI regulatory frameworks.

Frameworks we assess against

NIST AI RMF 1.0
ISO/IEC 42001
FDA guidance on AI-enabled device software
ISO 14971 and IEC 62304
EU AI Act
Bank model-risk guidance

Who it is for

Healthcare and medical device AI vendors
Financial services AI vendors
Consultants who advise them
Buyers who want a consistent evidence format

Find your readiness gaps before a buyer does

The diagnostic takes about five minutes and needs no sign-up. Founding beta clients can request a full evaluation at no charge. An NDA and MSA are signed before any access.

Take the free readiness diagnostic Request an evaluation