Design Control

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.

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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design elements and live traceability verification using dashboards to check if traceability is broken, missing, or outdated.

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Manage verification and validation activities

Matrix Requirements® enables you to create and execute test protocols and test cases that are directly traceable to specific requirements. This process automatically generates timestamped test results records, ensuring that your design control approach conforms to regulatory standards.

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.

Create new design from existing ones

The Compose feature is an advanced Matrix Requirement® capability designed to help you organize the development of large products or product variations by allowing you to split development into independent projects.

  • The module allows you to bring categories and items from a master project into new projects and synchronize changes made in the master project.

  • It also enables you to copy information from one project to another and modify it as needed, without any subsequent synchronization.

  • The content transferred from one project to another can be rendered specifically based on your needs, even if it is included from another project.

Branch and Merge development projects

The Branching and Merging feature is an advanced Matrix Requirement® set of functionalities used to create independent branches for parallel development and manage changes in the main project database.

  • With the Branching functionality, you can create independent branches for simultaneous work, preventing conflicts and maintaining main project base stability. Each branch provides an isolated environment for changes, enabling experimentation without risk to the project.

  • You can then merge completed and tested branch changes into the main project base with tools to efficiently identify and resolve merge conflicts. Each branch has configuration options in its project settings, allowing you to exclude specific categories or fields from merging, define merge permissions for users, and set how labels are handled during a merge.

  • Branch changes and merges are tracked and project history kept for traceability and version control. Sharing branches for collaboration and review is also a possibility.

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