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




































































































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.