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.
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
