Consumer Health Devices with Matrix Req
Matrix Req supports the development of consumer-facing medical technologies with a flexible, scalable platform.
For taking a demo with our team.
The challenge
Consumer health devices must move fast without cutting corners on compliance
From wearable trackers and at-home diagnostic tools to connected health apps and personal monitoring devices, consumer health products sit at the intersection of rapid innovation and regulatory scrutiny. Teams must deliver intuitive, connected experiences at consumer speed — while meeting increasingly strict regulatory requirements across global markets.
- Speed vs. compliance tension:Fast-paced consumer development cycles are hard to reconcile with the structured documentation and traceability that regulators require.
- Connectivity and interoperability complexity:Managing requirements and risks related to Bluetooth, mobile apps, and cloud integrations across multiple platforms adds significant development overhead.
- Usability and user experience requirements:Consumer devices must meet IEC 62366-1 usability engineering standards — ensuring safe, effective experiences for non-clinical users.
Our solution
Move fast, stay compliant without choosing one over the other
Matrix Req gives consumer health device teams a flexible, scalable platform to manage requirements, risks, tests, and documentation built for the pace of consumer markets without sacrificing regulatory rigor. Whether you're developing Class I wearables or Class II connected monitoring devices, Matrix Req adapts to your development approach and regulatory pathway.
- Iterate quicklywith Agile-compatible workflows that maintain full traceability at every sprint.
- Stay compliantwith FDA, EU MDR, and other regional requirements — with documentation built for both Class I and II device submissions.
- Manage connectivity confidentlyrequirements and risks for Bluetooth, mobile apps, and cloud integrations, all in one platform.
Core Features
Purpose-built capabilities for consumer health device development teams.
Usability Engineering & IEC 62366-1 Support
Integrate human factors and usability testing into your development process — ensuring your device delivers a safe and effective experience for everyday consumers, not just clinical users.
Global Regulatory Coverage
Navigate FDA, EU MDR, and other regional requirements confidently — with documentation and traceability that supports both Class I and II device submissions across global markets.
Connectivity & Interoperability Support
Manage requirements and risks related to Bluetooth, mobile apps, and cloud-based data integrations — keeping connectivity concerns fully traceable alongside your core device requirements.
Rapid Iteration for Consumer Markets
Enable fast-paced development cycles while maintaining rigorous traceability and compliance — with Agile-compatible workflows that keep your team moving without creating documentation debt.
Technical Documentation Generation
Generate audit-ready technical files automatically from your live project data — in PDF, Word, or HTML — ready for regulatory submissions at any stage of development.
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
