Consumer Health Devices with Matrix Requirements®
Matrix Requirements® supports the development of consumer-facing medical technologies with a flexible, scalable platform.
The challenge
Our solution
Core Features
Purpose-built capabilities for consumer health device development teams.
Usability Engineering & IEC 62366-1 SupportIntegrate 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 CoverageNavigate 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 SupportManage 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 MarketsEnable 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 GenerationGenerate 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
Matrix One is trusted by 500+ Life Sciences & Medical Device Companies
