Answer 14 plain-language questions about your AI tool, device class, and regulatory status. Get a compliance readiness score, gap analysis, and recommended evaluation tier — free, in under 5 minutes.
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Device Profile
AI Profile
Regulatory Status
Compliance Gaps
// Step 01 of 04
Tell us about your device
We need to understand what your AI tool does and how it is classified — this determines which regulatory frameworks apply.
What does your AI tool do? *
Brief description — e.g. "analyzes X-ray images to detect lung nodules" or "automates prior authorization decisions"
What is your device regulatory classification? *
Select the highest applicable classification
How is your AI software deployed? *
What is your IEC 62304 software safety classification?
Class A = no injury possible · Class B = non-serious injury possible · Class C = serious injury or death possible
* Required fields
// Step 02 of 04
Tell us about your AI
The type of AI model you use determines which evaluation frameworks apply and how complex the assessment will be.
What type of AI model does your device use? *
Does your AI use a third-party foundation model or API? *
Examples: Claude API, OpenAI GPT-4, Google Gemini, AWS Bedrock, Azure OpenAI, Hugging Face models
How does your AI model change or update after deployment? *
How is your AI device connected?
// Step 03 of 04
Your regulatory status
Tell us where you are in the regulatory process — this determines the urgency of your compliance gaps.
Which markets are you targeting? *
Select all that apply
What is your current regulatory submission status? *
Are you aware of your EU AI Act obligations?
The EU AI Act has two key deadlines: December 2, 2027 (Annex III high-risk AI) and August 2, 2028 (Annex I product-linked AI)
// Step 04 of 04
Your compliance readiness
Final questions about your current documentation and validation status — these directly determine your readiness score.
Has your AI been tested against specific regulatory frameworks? *
Has your AI been tested for demographic bias? *
FDA and CMS require equal performance across age, sex, race, and geography
Do you have an independent third-party assessment of your AI? *
Internal testing alone does not satisfy hospital legal teams or regulatory bodies
Do you have a post-deployment monitoring plan for your AI?
FDA PCCP Final Guidance (August 2025) requires a Predetermined Change Control Plan for AI medical devices
// Your Assessment Results
Your AI Compliance Readiness Score
// Enter your work email to see your full results
// No spam. Your results are confidential. We will email you a copy.
// ClearanceAI Readiness AssessmentRESULTS
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/ 100
Compliance Readiness Score
Calculating...
⚠ Critical Gap Detected — One or more critical compliance requirements are unmet. Regardless of other scores, this must be resolved before deployment. See findings below.
Regulatory Alignment
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Bias & Fairness
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Independent Evidence
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Post-Deploy Monitoring
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AI Architecture Risk
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// Regulatory Clause Gap Analysis
Critical Gap
Moderate Gap
Requirement Met
Framework
Clause / Section
Requirement
Your Status
Gap Severity
// This gap analysis is based on your self-reported compliance status. A ClearanceAI Layer 1 or Layer 2 evaluation will verify each clause against your actual AI model documentation and produce a formally auditable gap report.