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
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
