CAREXDATA

Independent Compliance Verification for Medical AI

Helping healthcare organizations and device manufacturers verify that AI-powered medical software meets regulatory standards — before it reaches patients.

Book a Demo Our Solutions

Our Solutions

AI Software Compliance Verification

Automated verification of AI-enabled medical devices against FDA, EU AI Act, IEC 62304, and ISO 13485 requirements. From training data to deployed models — we check the full lifecycle.

Learn More

CarexData Compliance Score (CCS)

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

Learn More

Continuous Monitoring

Post-market compliance surveillance for deployed AI systems. Track model drift, performance degradation, and emerging vulnerabilities as required under FDA PCCP and EU AI Act.

Learn More

Why CarexData

Independent & Rigorous

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

Built for AI

Purpose-built for AI-specific compliance challenges — model fairness, adversarial robustness, data bias, AI-generated code verification — that generic QA tools don't address.

Regulation-Ready

Every assessment maps directly to current FDA, EU MDR, and international standards. Reports are structured for direct inclusion in regulatory submissions.

The compliance layer for medical AI

AI is increasingly responsible for building medical devices — writing diagnostic algorithms, generating training data, even drafting regulatory submissions. As AI takes on more of the development process, independent compliance verification becomes essential.

CarexData provides that verification layer. Our platform checks AI-powered medical software against the regulatory standards that matter — FDA TPLC, PCCP, EU AI Act, IEC 62304, and ISO 13485 — and produces standardized, auditable compliance reports.

FDA TPLC
EU AI Act
IEC 62304
ISO 13485
FDA PCCP
EU MDR
6 Assessment Dimensions
100% Independent
Peer Reviewable Methodology
Open Methodology

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 is grounded in published, peer-reviewable research.

CarexData is an independent software company focused on regulatory compliance verification. We do not provide marketing analytics, advertising technology, or customer intelligence services.

Research & Publications

We're committed to advancing medical AI compliance through rigorous, transparent methodology. Our framework is designed to be cited, challenged, and improved by the research community. We welcome partnerships with regulatory bodies, academic institutions, and standards organizations.

Methodology

CCS Methodology Framework v1.0

CarexData Research, April 2026

A standardized framework for rating medical AI software compliance across six assessment dimensions — fidelity, representativeness, robustness, documentation, security, and transparency.

Download Methodology
Forthcoming

AI-Generated Code in Medical Devices

Forthcoming, Q3 2026

Examining the compliance challenges of AI-generated source code in IEC 62304-regulated medical software — hallucination detection, safety classification, and human review protocols.

Pre-register Interest

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.

Contact Research Team
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.