Design Control features inside Matrix Req
Matrix Req 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.
Design control is hard to scale without the right foundation
One platform to connect, trace, and control every design decision
Broken traceability
Links between requirements, design outputs, and tests are manually maintained and easily lost.
Implement your design control strategy your way
Configure the design categories, item types, and traceability rules that match your regulatory and development approach.
Slow impact analysis
Identifying the full scope of a change requires searching across multiple documents and tools.
See the full impact of any change in seconds
Not days with end-to-end traceability across requirements, risks, and tests.
Compliance gaps
Audit readiness is a reactive, time-intensive exercise rather than an always-on capability.
Stay audit-ready at all times
With automatically timestamped records, change history, and approval workflows.
Fragmented development
Parallel workstreams create conflicting versions with no clear merge path.
Scale across products and teams
Through branching, merging, and project composition features built for complex device portfolios.
Design control is hard to scale without the right foundation
Broken traceability
Links between requirements, design outputs, and tests are manually maintained and easily lost.
Slow impact analysis
Identifying the full scope of a change requires searching across multiple documents and tools.
Compliance gaps
Audit readiness is a reactive, time-intensive exercise rather than an always-on capability.
Fragmented development
Parallel workstreams create conflicting versions with no clear merge path.
One platform to connect, trace, and control every design decision
Implement your design control strategy your way
Configure the design categories, item types, and traceability rules that match your regulatory and development approach.
See the full impact of any change in seconds
Not days with end-to-end traceability across requirements, risks, and tests.
Stay audit-ready at all times
With automatically timestamped records, change history, and approval workflows.
Scale across products and teams
Through branching, merging, and project composition features built for complex device portfolios.
Core Features
Purpose-built tools to manage every aspect of your medical device design process.
Usability Engineering: Integrate human factors and usability testing into your process.
Global Regulatory Coverage: Support FDA, MDR, and other regional requirements.
Connectivity Support: Manage requirements and risks related to Bluetooth, mobile apps, and cloud.
End-to-end Traceability: Identify affected requirements, risks, and tests in real time.
Integrated Risk Assessment: Evaluate consequences on device safety and performance.
Change Management: Every change reviewed, documented, and approved.
Master Project Sync: Bring items from a master project and keep them updated.
Flexible Copying: Copy and adapt content independently, without synchronization.
Customizable Output: Render content to fit the needs of each project.
Independent Branching: Isolate changes for experimentation without risk.
Flexible Merging: Merge changes back with built-in conflict resolution.
Full Audit Trail: Track all changes for traceability and version control.
Auto-Generation: Produce clear requirements and matching test cases instantly.
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 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
