Design Control & impact analysis with Matrix Requirements.

Matrix Requirements® uses an item-based approach to easily manage all your design elements in a database with a unique identifier and link them to establish end-to-end traceability to ensure compliance and safe design.

Trusted by 300+ Connected Medical Device Companies

Use Matrix Requirements® to implement your own design control strategy

Whatever your requirement management plan, verification strategy and risk management system, you can create all design categories you need to manage your design items, from design inputs to design outputs, including tests and risks.

Establish, maintain and manage traceability

The creation of traceability rules between design item categories results in a design tree structure.

  • This design item connection allows managing complex associations between design elements and live traceability verification using dashboards to check if traceability is broken, missing, or outdated.

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Impact Analysis

Matrix Requirements® facilitates impact analysis through its end-to-end traceability and change control features.

  • By maintaining complete requirements traceability with Matrix Requirements®, you can instantly identify the affected requirements, design elements, risks, and tests.

  • Integrated risk assessment tools further enable evaluation of potential consequences on device safety and performance.

  • Matrix Requirements® change management workflow ensures that all changes are properly reviewed, documented, and approved.

Hear from our customers

"Matrix Requirements makes it very straightforward to write requirements and link them to specifications, risks and test cases"

Aurélie Gruener, Quality and Regulatory Affairs Director