Webinar: Connecting your Device to the Cloud: A Primer on Matrix Connect
Orthopedic Devices with Matrix Requirements®
Orthopedic devices must be developed with precision and full compliance with international standards. Matrix Requirements® equips orthopedic manufacturers with the tools needed to manage evolving requirements.
The challenge
Our solution
Core Features
Purpose-built capabilities for therapeutic 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
