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.
For taking a demo with our team.
The challenge
Design control is hard to scale without the right foundation
Managing design control across disconnected tools makes traceability hard to maintain and impact analysis slow. When a change happens, teams struggle to understand what's affected — and compliance gaps can go undetected until an audit. Common pain points include:
- Broken traceabilityLinks between requirements, design outputs, and tests are manually maintained and easily lost.
- Slow impact analysisIdentifying the full scope of a change requires searching across multiple documents and tools.
- Compliance gapsAudit readiness is a reactive, time-intensive exercise rather than an always-on capability.
- Fragmented developmentParallel workstreams create conflicting versions with no clear merge path.
Our solution
One platform to connect, trace, and control every design decision
Matrix Req gives every design element a unique identifier and a clear set of relationships to other items. When a change occurs, the full impact is visible instantly — no chasing documents, no guesswork. Matrix Req helps you:
- Implement your design control strategy your wayConfigure the design categories, item types, and traceability rules that match your regulatory and development approach.
- See the full impact of any change in secondsNot days with end-to-end traceability across requirements, risks, and tests.
- Stay audit-ready at all timesWith automatically timestamped records, change history, and approval workflows.
- Scale across products and teamsThrough 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.
Establish, Maintain and Manage Traceability
Link design items across categories to build a structured design tree. Instantly spot traceability that is broken, missing, or outdated.
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.
Impact Analysis
See the full impact of any change instantly.
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.
Create New Designs from Existing Ones
Reuse existing projects to accelerate development of new products or variants.
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.
Manage Verification and Validation Activities
Create 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 Projects
Run parallel workstreams without destabilizing your main 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.
Accelerate Development with AI-Powered Requirements
Generate compliant requirements and test cases from your product data — in minutes.
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.
Redlining Summary
AI built into the compare view: a plain-language summary of what changed between two versions of an item.
Traceability Checker
Finds missing links, judges whether existing links really hold, and suggests what should fill each gap.
Learn moreHear 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
