Implantable Devices with Matrix Requirements®
Implantable device products must meet the highest standards of biocompatibility, safety, and performance. Matrix Requirements® delivers the end-to-end support needed to navigate these demanding lifecycles.
The challenge
Our solution
Core Features
Purpose-built capabilities for implantable device development teams.
Long-Term Risk & Safety ManagementComprehensively document and manage risk in accordance with ISO 14971 and device-specific standards such as ISO 14708 and ISO 5840 — covering the full device lifecycle from design through post-market activities.
Biocompatibility & Material TraceabilityMaintain full traceability of materials, coatings, and sterilization processes to support biocompatibility requirements and implant safety documentation — with no gaps in your design history.
Complex System EngineeringCoordinate interdisciplinary development across electronics, software, mechanical design, and clinical validation in a unified environment — keeping all teams aligned and all artifacts traceable.
Post-Market Surveillance IntegrationExtend traceability into post-market feedback and vigilance reporting to support ongoing compliance and lifecycle improvements — fully integrated via the eQMS module.
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
