Clinical Trials for Wearable Medical Devices: What Sponsors Need to Know in 2025

Wearable medical technology is reshaping diagnostics, monitoring, and chronic disease management. But clinical trials for wearables face unique challenges. At Parameters Research Lab, we help guide sponsors through the nuances of testing and validating wearable devices in the current regulatory landscape. 

1. Accuracy Validation Across Skin Tones and Conditions 

From pulse oximeters to cuffless BP monitors, sensor accuracy must hold across diverse skin tones, body types, and environmental settings. Parameters Lab recruits for inclusion and tests across real-world scenarios, ensuring your data stands up to various scrutiny. 

2. App Integration and Data Synchronization 

Many wearable devices include companion apps that record, interpret, or transmit physiological data. We can validate both hardware and software interfaces under test conditions, including data integrity, quality, and assess UI-based error risks. 

3. ISO and FDA Pathways for Wearables 

Wearables often trigger ISO 81060-2, 14155, and even 62304 if software is involved. We help to design and execute trials that satisfy these standards and align with the FDA’s SaMD and digital health guidance. 

Conclusion: Next-Gen Devices Demand Next-Gen Trials 

The future of healthcare is wearable, but regulators still need proof of accuracy. At Parameters Lab, we deliver development and validation studies that can include human factors, robust protocol design, and regulatory fluency. Whether you're building a wearable device, blood pressure cuff, or other devices, we’re ready to help. 

📩 Ready to validate your wearable device? Contact Parameters Lab to design a study that meets both technical and regulatory demands. 

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