Orthopedic Devices with Matrix Req
Orthopedic devices must be developed with precision and full compliance with international standards. Matrix Req equips orthopedic manufacturers with the tools needed to manage evolving requirements.
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The challenge
Orthopedic device development is complex, highly regulated, and increasingly customized
From spinal implants and internal fixation hardware to custom prosthetics and orthotics, orthopedic devices restore mobility and quality of life for millions of patients worldwide. Developing these devices demands rigorous mechanical design, biocompatibility validation, and full compliance with global regulatory standards — while managing an increasing demand for patient-specific and modular configurations.
- Complex mechanical and material requirements:Tracking specifications, tolerances, and validated materials across product variants is difficult without a structured, traceable system.
- Multiple global regulatory pathways:Meeting EU MDR, FDA 21 CFR Part 820, ISO 13485, and device-specific standards simultaneously requires structured documentation and traceability across markets.
- Patient-specific and modular designs:Managing configurable and custom device variants while maintaining regulatory compliance adds significant complexity to design control.
Our solution
A structured platform that scales with orthopedic complexity
Matrix Req gives orthopedic device teams a single platform to manage design control, risk, verification, and documentation — across standard products, modular systems, and patient-specific configurations. Whether you're developing spinal implants, fixation hardware, or custom prosthetics, Matrix Req adapts to your design strategy and regulatory pathway.
- Maintain full traceabilityfrom design inputs to outputs, verification, and risk controls — across mechanical, material, and clinical elements.
- Stay compliantwith EU MDR, FDA 21 CFR Part 820, ISO 13485, and other applicable standards in one platform.
- Manage complexity confidentlyfrom standard products to patient-specific configurations — with reusable, traceable design elements.
Core Features
Purpose-built capabilities for orthopedic device development teams.
MDR, 21 CFR Part 820 & ISO 13485 Compliance Support
Ensure full compliance with EU, US, and global regulatory frameworks — with structured workflows, documentation, and traceability built for orthopedic device submissions.
Mechanical Design & Material Traceability
Track specifications, tolerances, and validated materials to ensure strength, durability, and biocompatibility — with full traceability across all design elements and product variants.
Patient-Specific & Modular Configuration Management
Support configurable designs and individual customizations with reusable, traceable design elements and variants — maintaining compliance across the full product range.
End-to-End Verification & Test Management
Streamline mechanical, biomechanical, and clinical testing workflows with full traceability to requirements and risk controls — keeping your design history file always audit-ready.
Technical Documentation Generation
Generate audit-ready technical files automatically from your live project data — in PDF, Word, or HTML — ready for regulatory submissions at any stage of development.
Hear from our customers
With Matrix Req, we avoid all the challenges of using manual or custom-developed tools. Instead, we get a purpose-built solution that’s designed by medical device experts, enabling much faster ISO 13485 compliance.”
François Audéon, Chief Technology Officer
