Consumer Health Devices with Matrix Requirements®

Matrix Requirements® supports the development of consumer-facing medical technologies with a flexible, scalable platform.

Trusted by 300+ Connected Medical Device Companies

Consumer Health Devices are at the heart of Matrix Requirements

Consumer Health Devices bridge personal wellness and clinical care, empowering individuals to monitor and manage their health daily. From wearable trackers to at-home diagnostic tools, these products require intuitive design, seamless connectivity, and compliance with evolving regulatory frameworks. Matrix Requirements® supports the development of consumer-facing medical technologies with a flexible, scalable platform that ensures quality, usability, and regulatory alignment:

  • IEC 62366-1 and Usability Engineering Support: Integrate human factors and usability testing into your development process to ensure safe and effective user experiences.

  • Global Regulatory Coverage: Navigate FDA, MDR, and other regional requirements confidently, with documentation that supports both Class I and II device submissions.

  • Connectivity and Interoperability Support: Manage requirements and risks related to Bluetooth, mobile apps, and cloud-based data integrations.

  • Rapid Iteration for Consumer Markets: Enable fast-paced development cycles while maintaining rigorous traceability and compliance with applicable standards.

Hear from our customers

Matrix Requirements is super effective at handling the complex relationships between design objects, and its user-friendliness convinced us that we’d found the perfect fit for our quality and requirements management needs.”

Michael Strelow, Quality Manager, ViViRA