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.
The challenge
Our solution
Core Features
Purpose-built capabilities for surgical instrument development teams.
ISO 14971 & IEC 60601-1 Compliance SupportAlign risk management and electrical safety standards within your development process — with structured workflows, documentation, and traceability that support global regulatory approval.
Design Control & TraceabilityEnsure 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 SupportManage 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 DocumentationTrack material specifications, sterilization validations, and reprocessing instructions with precision and consistency — ensuring your documentation meets regulatory expectations for reusable devices.
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
