Surgical Instruments with Matrix Requirements®
Surgical instrumentation must meet stringent design controls and documentation standards. Matrix Requirements® provides a robust framework to manage their inherent complexities.
Surgical Instruments are at the heart of Matrix Requirements
Surgical Instruments range from precision manual tools to advanced robotic systems, playing a vital role in ensuring successful outcomes in the operating room. Whether developing reusable instruments, minimally invasive devices, or software-driven surgical platforms, manufacturers must meet stringent design controls and documentation standards. Matrix Requirements® provides a robust framework to manage these complexities, enabling teams to accelerate innovation while maintaining full regulatory compliance:
ISO 14971 and IEC 60601-1 Compliance Support: Easily align risk management and electrical safety standards within your development process, supporting global regulatory approval.
Design Control and Traceability: Ensure every design input, output, verification, and validation activity is traceable and audit-ready, from concept to finished product.
Robotic and Software-Integrated Device Readiness: Manage hybrid development involving hardware, electronics, and embedded software in robotic surgical systems.
Reuse and Sterilization Documentation: Track material specifications, sterilization validations, and reprocessing instructions with precision and consistency.
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
