Implantable Devices with Matrix Req
Implantable device products must meet the highest standards of biocompatibility, safety, and performance. Matrix Req delivers the end-to-end support needed to navigate these demanding lifecycles.
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The challenge
Implantable devices carry the highest regulatory and safety burden in MedTech
From pacemakers and neurostimulators to artificial joints and orthopedic implants, implantable devices operate long-term inside the human body — where the consequences of failure are severe and often irreversible. Development teams must manage extraordinary complexity: multi-disciplinary engineering, stringent biocompatibility requirements, long-term risk management, and some of the most demanding regulatory pathways in the industry.
- Highest-risk classification:Implantable devices are typically Class III, requiring clinical evidence, extensive technical documentation, and rigorous pre-market approval across multiple jurisdictions.
- Biocompatibility and material traceability:Every material, coating, and sterilization process must be fully documented and traceable — with no room for gaps.
- Lifecycle complexity:Compliance doesn't end at market approval. Post-market surveillance, vigilance reporting, and design change management must be maintained throughout the device's entire lifecycle.
Our solution
End-to-end support for the full implantable device lifecycle
Matrix Req gives implantable device teams a single, structured platform to manage design control, risk, documentation, and post-market activities — from initial concept through to ongoing surveillance. Whether you're developing active electronic implants or passive mechanical devices, Matrix Req adapts to your regulatory pathway and keeps your team audit-ready at every stage.
- Maintain full traceabilityacross materials, electronics, software, and clinical validation — in one connected project.
- Stay compliantwith ISO 14971, ISO 14708, ISO 5840, EU MDR, FDA, and other applicable standards.
- Extend traceability into post-marketwith integrated feedback and vigilance reporting support via the eQMS module.
Core Features
Purpose-built capabilities for implantable device development teams.
Long-Term Risk & Safety Management
Comprehensively 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 Traceability
Maintain 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 Engineering
Coordinate 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 Integration
Extend traceability into post-market feedback and vigilance reporting to support ongoing compliance and lifecycle improvements — fully integrated via the eQMS module.
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
