Independent compliance verification

The Trust Layer for Medical AI

We verify that AI-powered medical devices meet FDA, EU AI Act, and international regulatory standards — so healthcare organizations and device manufacturers can move forward with confidence.

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FDA 510(k) & De Novo EU AI Act IEC 62304 ISO 13485 FDA PCCP
6 Assessment Dimensions
8+ Regulatory Frameworks
100% Independent
Open Peer-Reviewable Methodology

Our Solutions

Purpose-built tools for the unique compliance challenges of AI in healthcare

AI Software Compliance Verification

Automated verification of AI-enabled medical devices against FDA, EU AI Act, IEC 62304, and ISO 13485 requirements. We check the full lifecycle — from training data provenance to deployed model behavior.

  • Training data bias and representativeness analysis
  • Model robustness and adversarial testing
  • Documentation completeness verification
  • Software lifecycle compliance mapping
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CarexData Compliance Score (CCS)

A standardized, independent quality rating for medical AI software. Device manufacturers include CCS reports in regulatory submissions as third-party evidence of compliance readiness.

  • Quantified scores across 6 assessment dimensions
  • Structured reports for FDA and EU submissions
  • Benchmarking against industry standards
  • Actionable remediation guidance
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Continuous Monitoring

Post-market compliance surveillance for deployed AI systems. Track model drift, performance degradation, and emerging regulatory requirements in real time.

  • Real-time model drift detection
  • Automated alerts for compliance gaps
  • FDA PCCP and EU AI Act post-market tracking
  • Audit-ready reporting dashboards
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How It Works

From initial assessment to continuous compliance — in three steps

01

Connect Your Pipeline

Integrate CarexData with your existing ML development workflow. We analyze your training data, model architecture, documentation, and deployment configuration — with minimal disruption to your team.

02

Automated Assessment

Our platform evaluates your AI system across six dimensions: fidelity, representativeness, robustness, documentation, security, and transparency. Each maps directly to FDA, EU AI Act, and IEC 62304 requirements.

03

Compliance Reports & Monitoring

Receive your CarexData Compliance Score with detailed findings, remediation steps, and submission-ready reports. Then shift to continuous monitoring that tracks your compliance posture as your model and the regulatory landscape evolve.

Why CarexData

Built by researchers who understand both AI and regulation

Truly Independent

We don't build AI devices — we verify them. Our independence gives regulatory teams and procurement committees the unbiased third-party assurance they need to approve AI systems.

Purpose-Built for AI

Generic QA tools miss AI-specific risks. We test for model fairness, adversarial robustness, data bias, AI-generated code safety, and hallucination — the issues that make medical AI unique.

Regulation-Ready Reports

Every assessment maps directly to current regulatory requirements. Reports are structured for direct inclusion in 510(k), De Novo, EU MDR Technical Documentation, and post-market submissions.

Research-Grounded

Our methodology is based on published, peer-reviewable research — not proprietary black boxes. We believe the compliance standard for medical AI should be as transparent as the devices it evaluates.

The compliance gap in medical AI

AI is increasingly responsible for building medical devices — writing diagnostic algorithms, generating training data, even drafting regulatory submissions. But the tools for verifying this software haven't kept pace.

Traditional QA processes were designed for deterministic software. They can't evaluate whether a training dataset is representative, whether a model is robust against adversarial inputs, or whether AI-generated code meets IEC 62304 safety classifications.

That's the gap CarexData fills. We bring AI-native compliance verification to the teams building the next generation of medical technology.

Radiologist reviewing medical imaging scans at a workstation
Medical professional reviewing brain CT scan images

Built on research, designed for industry

CarexData was founded by a team with PhDs in Computer Science and deep experience in medical imaging AI research. Our compliance methodology bridges the gap between academic rigor and regulatory reality.

The CarexData Compliance Score (CCS) evaluates AI medical software across six dimensions — fidelity, representativeness, robustness, documentation, security, and transparency — with each dimension directly traceable to specific regulatory requirements.

Our methodology is open and peer-reviewable. We believe the standard for medical AI compliance should be as transparent and evidence-based as the devices it evaluates.

Who We Serve

CarexData supports every stakeholder in the medical AI compliance chain

AI Medical Device Manufacturers

Preparing 510(k), De Novo, or CE mark submissions? Use CCS reports as third-party compliance evidence to strengthen your submission and reduce review cycles.

Hospitals & Health Systems

Evaluating AI tools for clinical use? Independent compliance scores give your procurement and clinical governance teams objective evidence for vendor assessment.

Regulatory Consultants

Advising clients on AI compliance strategy? Partner with CarexData to provide data-driven assessments alongside your regulatory expertise.

Research Institutions

Translating AI research tools to clinical use? CarexData helps identify compliance gaps early — before they become costly roadblocks to deployment.

Open for Collaboration

We welcome partnerships with research institutions, healthcare organizations, regulatory consultants, and industry leaders. If you're working on medical AI compliance, we'd love to hear from you.

Now accepting pilot partners

Be one of our first 10 pilot customers

We're looking for AI medical device companies preparing FDA or EU submissions to join our early access program. You get free compliance scans and a dedicated onboarding experience. We get your feedback to build the best product possible.

Ideal pilot partners

SaMD companies preparing 510(k) or De Novo AI device teams facing EU AI Act (Aug 2026) Startups with AI-generated code in medical software Research groups translating AI tools to clinical use
Apply for Early Access

Book a Demo

See how CarexData can support your regulatory compliance process. Schedule a personalized walkthrough with our team.