Matrix Audit Ready - Compliance Checker
AI-powered compliance verification — built for RAQA professionals who can't afford to get it wrong.
For taking a demo with our team.
The challenge
Manual compliance processes are slowing down your team
Manual compliance checking is one of the most time-intensive activities in medical device development. RAQA professionals and engineers spend weeks — sometimes months — extracting requirements from regulatory standards, cross-referencing technical documentation, and manually assessing compliance status. The result: delayed submissions, bottlenecks before audits, and teams stretched thin on work that should be systematic and repeatable.
- Time-consuming by default:Manually reviewing standards and mapping them to documentation takes months, not days.
- Hard to keep current:As standards evolve and documentation changes, maintaining an up-to-date compliance picture is a constant challenge.
- High risk of gaps:Manual processes are prone to missed requirements and inconsistent assessments across team members.
Our solution
Accelerate compliance reviews without losing control
The Matrix Compliance Checker leverages AI to automate the extraction and assessment of regulatory requirements — turning a months-long process into a structured, traceable workflow that takes a fraction of the time. It analyzes your technical documentation against regulatory standards and delivers clear, structured compliance assessments. And because it's built for a regulated industry, every result goes through your review before anything is documented.
- Accelerate compliance workflowswithout sacrificing rigor or accuracy.
- Reduce manual efforton repetitive requirement extraction and cross-referencing.
- Stay audit-readywith structured, traceable assessment results at every stage.
Core Features
Purpose-built to make compliance verification faster, safer, and more traceable.
AI-Powered Requirement Extraction
Automatically extract requirements from regulatory standards and technical specifications, eliminating hours of manual cross-referencing and reducing the risk of missed requirements.
Standard to Project Mapping
Ingest regulatory checklists from ISO 13485, IEC 62304, ISO 14971, EU MDR and more and systematically evaluate every requirement against your actual project evidence in Matrix One.
Automated Compliance Assessment
Analyze your technical documentation against extracted requirements and receive structured, traceable compliance assessments in a fraction of the time traditional methods require.
Dedicated Review Interface
All AI-generated results are surfaced in a clear review interface where your team can evaluate, validate, and decide what to incorporate, keeping human expertise at the center of every compliance decision.
Export & Traceability
Export assessment results as CSV files for thorough review and team collaboration. Every assessment is structured and traceable, supporting audit-ready documentation workflows.
Parallel Assessment & Calibrated Severity
Processes large checklists of 100+ items efficiently using multiple AI sub-agents working in parallel. An built-in "auditor test" avoids false positives by giving credit for substance over form.
How We Keep You in Control
AI that assists, never decides: We know that in a regulated environment, trust is everything. The Compliance Checker is designed so that your team remains in full control of every compliance decision.
Human Review First: All AI-generated assessments are presented in a dedicated review interface. Nothing is added to your documentation automatically — every recommendation requires your expert validation before it is acted upon.
Full Export for Thorough Review: Results can be exported as CSV files, giving you and your team the flexibility to review, discuss, and validate assessments outside the platform before incorporating them into your technical documentation.
Zero Data Retention: Your data stays yours. Third-party providers process customer data temporarily and do not retain or reuse it. Customer data is never used for AI model training or improvement. Matrix One does not share, sell, or disclose customer data.
Hear from our customers
The Compliance Checker cut our pre-audit preparation time dramatically. What used to take our team weeks of manual cross-referencing is now done in a structured, traceable way — and we stay in full control of every decision.
Laura Mitchell, Regulatory Affairs Manager
