Surgical Instruments with Matrix Req
Surgical instrumentation must meet stringent design controls and documentation standards. Matrix Req provides a robust framework to manage their inherent complexities.
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The challenge
Surgical instruments demand precision — in the operating room and in documentation
From precision manual tools to advanced robotic surgical systems, surgical instruments operate in some of the highest-stakes environments in medicine. Development teams must manage complex design requirements, stringent safety standards, and detailed documentation — while navigating the added complexity of reusable devices, sterilization validation, and increasingly software-driven platforms.
- Wide device complexity:Managing development across manual instruments, minimally invasive devices, and robotic surgical systems requires a flexible, structured approach that most tools can't support.
- Stringent safety and compliance requirements:Meeting ISO 14971, IEC 60601-1, EU MDR, and FDA requirements simultaneously demands structured traceability from design input to final verification.
- Reuse and sterilization documentation:Tracking material specifications, sterilization validations, and reprocessing instructions accurately is time-consuming and error-prone without a dedicated system.
Our solution
A structured platform that keeps pace with surgical instrument complexity
Matrix Req gives surgical instrument development teams a single platform to manage design control, risk, verification, and documentation — from simple manual tools to complex robotic systems. Whether your device is reusable, single-use, or software-integrated, Matrix Req adapts to your development process and regulatory pathway.
- Maintain full traceabilityfrom design inputs to outputs, verification, and risk controls — across hardware, electronics, and embedded software.
- Stay compliantwith ISO 14971, IEC 60601-1, EU MDR, FDA, and other applicable standards in one platform.
- Accelerate submissionswith structured documentation generated automatically from your live project data.
Core Features
Purpose-built capabilities for surgical instrument development teams.
ISO 14971 & IEC 60601-1 Compliance Support
Align risk management and electrical safety standards within your development process — with structured workflows, documentation, and traceability that support global regulatory approval.
Design Control & Traceability
Ensure every design input, output, verification, and validation activity is traceable and audit-ready — from concept through to finished product. Keep your Design History File always current and complete.
Robotic & Software-Integrated Device Support
Manage hybrid development involving hardware, electronics, and embedded software in robotic and software-driven surgical systems — maintaining full traceability across all components in a single project.
Reuse & Sterilization Documentation
Track material specifications, sterilization validations, and reprocessing instructions with precision and consistency — ensuring your documentation meets regulatory expectations for reusable devices.
Technical Documentation Generation
Generate 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
