Therapeutic Devices with Matrix Req
Therapeutic devices demand uncompromising safety, reliability, and regulatory rigor. Matrix Req is purpose-built to support the development of therapeutic technologies.
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The challenge
Therapeutic devices leave no room for error — in design or in compliance
From infusion pumps and ventilators to dialysis machines and surgical systems, therapeutic devices directly impact patient outcomes. The stakes are high: any gap in safety, traceability, or documentation can delay a submission, trigger a recall, or put patients at risk. Development teams face the dual pressure of managing complex, safety-critical systems while meeting increasingly stringent regulatory requirements across multiple markets — all within competitive timelines.
- Safety-critical complexityHigh-risk functionalities like dosage control and respiratory support require rigorous, end-to-end verification and validation — with full traceability at every step.
- Hardware, firmware, and software integrationManaging requirements and design artifacts across interconnected systems is difficult without a unified platform.
- High regulatory burdenComplying with ISO 14971, IEC 60601-1, EU MDR, FDA, and other standards simultaneously requires structured processes that most tools can't support.
Our solution
A unified platform built for the complexity of therapeutic device development
Matrix Req gives therapeutic device teams a single, structured environment to manage requirements, risks, tests, and documentation across the full product lifecycle. From Class II to Class III devices, it adapts to your design control strategy and regulatory pathway — keeping your team aligned and audit-ready at every stage.
- Ensure full traceabilityacross hardware, firmware, and software — from user needs to design outputs, verification, and risk controls.
- 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 therapeutic device development teams.
ISO 14971 & IEC 60601-1 Compliance Support
Align risk management and electrical safety standards within your development process. Matrix Req supports the structured workflows, documentation, and traceability these standards require for global regulatory approval.
Embedded Software & Hardware Traceability
Link requirements, design, and test artifacts across complex systems combining hardware, firmware, and software — maintaining full traceability across all components in a single project.
Safety-Critical Functionality Support
Ensure high-risk functionalities — such as dosage control, alarm management, and respiratory support are thoroughly verified, validated, and traceable to their design inputs and risk controls.
Real-Time Cross-Functional Collaboration
Keep engineering, quality, and regulatory teams aligned with shared project visibility, structured review workflows, and change control tools built for dynamic, regulated development environments.
Technical Documentation Generation
Generate audit-ready design history files and technical documentation automatically from your live project data — in PDF, Word, or HTML — ready for regulatory submissions at any stage.
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
