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.

The challenge

Our solution

Orthopedic device development is complex, highly regulated, and increasingly customized

A structured platform that scales with orthopedic complexity

Complex mechanical and material requirements:

Tracking specifications, tolerances, and validated materials across product variants is difficult without a structured, traceable system.

Maintain full traceability

from design inputs to outputs, verification, and risk controls — across mechanical, material, and clinical elements.

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.

Stay compliant

with EU MDR, FDA 21 CFR Part 820, ISO 13485, and other applicable standards in one platform.

Patient-specific and modular designs:

Managing configurable and custom device variants while maintaining regulatory compliance adds significant complexity to design control.

Manage complexity confidently

from standard products to patient-specific configurations — with reusable, traceable design elements.

The challenge

Orthopedic device development is complex, highly regulated, and increasingly customized

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

Maintain full traceability

from design inputs to outputs, verification, and risk controls — across mechanical, material, and clinical elements.

Stay compliant

with EU MDR, FDA 21 CFR Part 820, ISO 13485, and other applicable standards in one platform.

Manage complexity confidently

from 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 SupportEnsure full compliance with EU, US, and global regulatory frameworks — with structured workflows, documentation, and traceability built for orthopedic device submissions.

Mechanical Design & Material TraceabilityTrack 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 ManagementSupport configurable designs and individual customizations with reusable, traceable design elements and variants — maintaining compliance across the full product range.

End-to-End Verification & Test ManagementStreamline mechanical, biomechanical, and clinical testing workflows with full traceability to requirements and risk controls — keeping your design history file always audit-ready.

Technical Documentation GenerationGenerate 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

Matrix One is trusted by 500+ Life Sciences & Medical Device Companies