Differences in the Testing and Certification of Consumer-Grade Wearable Devices and Body-Worn Medical Devices

Technical note preview

Smart wearables claim to be able to monitor heart rates, breathing rates, menstrual cycles, sleep apnea and more. Tracking a user’s vital signs, displaying data in real-time, and comparing the values to healthy goals gives consumers the ability to constantly adjust their lifestyle to avoid certain health afflictions, such as stroke or cardiovascular disease. These devices also meet the demand from sophisticated consumers for products that serve several functions while remaining aesthetically appealing.

Some are optimistic that smart wearables will have validated clinical applications in future, to track level of activity objectively and quantitatively, to monitor whether health statistics are in a healthy range and to aid in diagnosing cardiovascular diseases, among other capabilities.

Manufacturers that produce smart wearables continue to strive for clinical validation and regulatory approval of their technology for use in detecting health conditions.

This technical note explores the differences in the testing and certification of consumer-grade wearable devices and body-worn medical devices.

This technical note covers the following topics:

  • The growing demand for remote patient monitoring;
  • The rise of consumer-grade smart wearable devices for health and fitness tracking;
  • Challenges with the certification of consumer-grade devices towards being recognized forr medical purposes; and
  • Certification of consumer-grade smart wearables and body-worn medical devices.