Diagnostic Equipment with Matrix Req
As diagnostic technology evolves, so do the expectations for traceability, documentation, and compliance. Matrix Req empowers development teams to meet these demands.
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The challenge
Diagnostic equipment demands precision — in design and in documentation
Diagnostic devices — from imaging systems and laboratory analyzers to point-of-care tools and wearable monitors — operate in high-stakes clinical environments where accuracy is critical. Development teams must navigate complex multi-disciplinary design, stringent regulatory requirements, and increasingly demanding technical documentation standards across multiple markets.
- Complex, multi-disciplinary design:Diagnostic equipment often combines hardware, software, and connectivity — each with its own compliance requirements that must be managed together.
- Strict performance and safety standards:Meeting IEC 60601, IVD regulations, and regional requirements requires structured, traceable development processes from day one.
- Growing documentation burden:Regulatory submissions for diagnostic devices require comprehensive technical files that are difficult to assemble and maintain without a dedicated system.
Our solution
A structured platform for diagnostic device development from design input to submission
Matrix Req gives diagnostic equipment teams a single platform to manage requirements, risks, tests, and documentation across the full product lifecycle. Whether you're developing Class II IVDs, imaging systems, or connected monitoring devices, Matrix Req adapts to your design control strategy and regulatory pathway.
- Maintain full traceabilityfrom user needs to design outputs, tests, and risk controls — across hardware, software, and connectivity components.
- Stay compliantwith IEC 60601, IVD regulations, EU MDR, FDA, and other applicable standards in a single platform.
- Accelerate submissionswith automatically generated, audit-ready technical documentation.
Core Features
Purpose-built capabilities for diagnostic equipment development teams.
End-to-End Design Control
Manage all design elements: inputs, outputs, tests, and risks in a structured, traceable database. Link every design decision to its regulatory rationale and keep your design history file always up to date.
Multi-Disciplinary Traceability
Maintain traceability across hardware, software, and connectivity components in a single project. Instantly surface the impact of any change across your full design from component level to system level.
Risk Management for Diagnostic Devices
Configure risk assessments tailored to your device type and classification — with support for ISO 14971 workflows, pre- and post-control assessments, and full traceability between risks and mitigations.
Regulatory Standards Coverage
Navigate IEC 60601, IVD regulations, EU MDR, FDA 510(k), and other regional requirements with confidence with built-in support for the documentation and traceability these standards demand.
Technical Documentation Generation
Generate audit-ready technical files automatically from your live project data in PDF, Word, or HTML and archive them securely for regulatory submissions.
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
