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.
Orthopedic Devices are at the heart of Matrix Requirements
Orthopedic Devices restore mobility, support musculoskeletal healing, and enhance quality of life for millions worldwide. From custom prosthetics and orthotics to complex spinal implants and internal fixation hardware, these 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, ensure design integrity, and meet regulatory demands across global markets:
MDR, 21CFR Part 820 and ISO 13485 Alignment Support: Ensure full compliance with UE, US and global regulatory frameworks for dental devices and quality systems.
Mechanical Design and Material Traceability: Track specifications, tolerances, and validated materials to ensure strength, durability, and biocompatibility.
Patient-Specific and Modular Configurations: Support configurable designs and individual customizations with reusable, traceable design elements and variants.
End-to-End Verification and Test Management: Streamline mechanical, biomechanical, and clinical testing workflows with full traceability to requirements and risk controls.
Hear from our customers
Matrix Requirements is super effective at handling the complex relationships between design objects, and its user-friendliness convinced us that we’d found the perfect fit for our quality and requirements management needs.”
Michael Strelow, Quality Manager, ViViRA
