Wearable Device Testing

Element provides end-to-end wearable device testing solutions from concept to market, including early R&D planning, compliance strategy development, pre-compliance testing, product compliance testing, and final certification. Our expert-guided approach helps identify and resolve potential issues early, streamlining your development process and reducing time to market for your wearable innovations.

Our wearable device testing includes: 

• Radio frequency performance 

• Specific absorption rate (SAR) 

• Wireless coexistence 

• Battery safety and performance 

• Environmental resilience 

• Drop and durability testing 

• Biocompatibility assessment 

• Electromagnetic compatibility (EMC) 

• Electrical Safety Testing 

• Cybersecurity testing 

For medical wearables, we provide: 

• Electrical medical safety testing (IEC 60601-1-11 for home healthcare equipment) 

• Protocol testing (Zigbee, Matter, Bluetooth, interoperability)  

• Regulatory submission preparation support 

Among our global network of laboratories specializing in wearables testing, the Element Boulder lab is the industry leader in clinical validation testing for medical wearables, with services including: 

• Formative and summative validation testing 

• Human factors evaluation 

• Blood Pressure Monitor Clinical Validation (invasive arterial and non-invasive following ISO 81060-2 and IEEE 1708) 

• Respiratory Rate Monitor Validation across specific demographics 

• Temperature Monitoring Device Clinical Validation 

• Pulse Oximetry Validation under controlled oxygen saturation conditions 

• Heart Rate Monitor Device Validation with FDA-cleared ECG simulator or monitor testing 

• Sleep Monitoring Device Validation 

• Consumer Devices and Wellness Products certification and claim validation 

• Human Factors Testing in clinical or home environments 

We test all critical components of wearable devices including battery systems, wireless modules, sensors, circuit boards, and materials that come into contact with skin. Our comprehensive testing ensures each element of your device functions correctly individually and as part of the integrated system, maintaining performance across varied use environments and throughout the product lifecycle.

Our laboratories are equipped with state-of-the-art testing technology for wireless communication testing, environmental simulation chambers, RF anechoic chambers, advanced measurement systems, and specialized wearable testing equipment. This advanced infrastructure allows us to provide precise, reliable results across the full spectrum of wearable device testing requirements, from consumer electronics to medical-grade monitoring equipment that must meet higher precision standards.

Element offers wearable device testing at our specialized laboratories across North America, Europe, and Asia. This global network enables us to provide local expertise combined with worldwide regulatory knowledge, supporting your market access needs wherever you plan to launch your wearable technology products. You can find your nearest lab on our Locations page.

Our global regulatory team specializes in navigating the complex landscape of wearable device approvals, including: 

• FCC (TCB) 

• FDA 

• ASCA FDA 

• ISED Canada (FCB) 

• EU (CE Marking) 

• Radio Equipment Directive (RED) 

• EU (Medical Device Regulation) 

• UK (UKCA Marking) 

• Japan (MIC Radio and Telecom laws) 

• KC (Korea) 

• Comprehensive global market access services