Design Control features inside Matrix Req

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.

The challenge

Our solution

Core Features

Purpose-built tools to manage every aspect of your medical device design process.

Establish, Maintain and Manage TraceabilityBuild a structured design tree by linking design items across categories. Live dashboards let you instantly spot traceability that is broken, missing, or outdated.

Usability Engineering: Integrate human factors and usability testing into your development process.
Global Regulatory Coverage: Support FDA, MDR, and other regional requirements for Class I and II devices.
Connectivity Support: Manage requirements and risks related to Bluetooth, mobile apps, and cloud integrations.
Rapid Iteration: Move fast without losing traceability or compliance.

Impact AnalysisInstantly identify everything affected by a change — requirements, design elements, risks, and tests — and act with confidence.

End-to-end Traceability: See the full impact of any change across your entire design in real time.
Integrated Risk Assessment: Evaluate consequences on device safety and performance without leaving the platform.
Change Management: Ensure every change is reviewed, documented, and approved through a structured workflow.

Create New Designs from Existing OnesReuse and extend existing projects to accelerate development of new products or variants — without starting from scratch.

Master Project Sync: Bring items from a master project into new projects and keep them automatically updated.
Flexible Copying: Copy and adapt content from any project independently, with no synchronization required.
Customizable Output: Render transferred content to fit the specific needs of each project.

Manage Verification and Validation ActivitiesCreate and execute test protocols and test cases directly traceable to your requirements. Every test automatically generates a timestamped result record, keeping your design control audit-ready at all times.

Branch and Merge Development ProjectsRun parallel workstreams without destabilizing your main project — then merge changes back with full control and traceability.

Independent Branching: Create isolated branches for simultaneous work, enabling experimentation without risk to the main project.
Flexible Merging: Merge tested changes back with built-in conflict resolution and configurable merge permissions.
Full Audit Trail: Track all branch changes and merges for complete traceability and version control.

Accelerate Development with AI-Powered RequirementsAutomatically generate structured, compliant requirements and test cases from your product data — in minutes, not days.

Auto-Generation: Produce clear requirements and matching test cases with minimal manual effort.
Better Coverage: Improve quality and reduce errors across your documentation.
Human-in-the-Loop: Stay in control with validation at every step.

Hear from our customers

With MatrixReq, 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

Trusted by 500+ Connected Medical Device Companies