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ESSpain
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Matrix One is trusted by 300+ Medical Device Companies Globally

Why choose Matrix One ?

Accelerate Regulatory Approval. Drive Cross-Functional Excellence. Medical device companies face intense pressure to innovate, meet compliance standards, and bring devices to market faster—all while ensuring internal teams are aligned. Matrix One is purpose-built to address these challenges.

For RA/QA TeamsSpeed Up Regulatory Time-to-Market — Without Sacrificing Compliance Centralized documentation and version control Automated workflows aligned with ISO and FDA standards Real-time collaboration for faster decision-making
For R&D LeadersInnovate Confidently — With Built-In Regulatory Alignment Seamless collaboration across RA/QA, Engineering, and Product Traceable design history files and risk management integration Reduced rework and audit readiness from day one

Product Features

  • Real-time data synchronization across teams

  • Integrated communication tools for seamless interaction

  • Built-in compliance support to standards like ISO 13485 and IEC 62304

  • Automated documentation to ensure traceability

  • Customizable workflows to fit your specific needs

  • Quick adaptation to changing regulatory requirements

  • Secure cloud storage for easy access and sharing

  • Comprehensive data analytics for informed decision-making

Hear from customers who’ve switched to Matrix Requirements

Their support during the migration and setup process was invaluable, and we successfully switched to the new solution after just two weeks.

Michael Strelow, Quality Manager, ViViRA

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