About Element Boulder
Element Boulder specializes in controlled human performance studies for connected and wearable health technologies. The laboratory conducts IRB-approved clinical validation and human factors protocols to evaluate device accuracy, usability, and real-world physiological performance.
Located on the AdventHealth Avista hospital campus between Boulder and Denver, Colorado, the facility operates dedicated clinical laboratories and maintains a broad network of hospital and research partners. This enables support for diverse study populations, complex physiological monitoring requirements, and multi-site validation programs.
The Boulder Quality Management System is built around ISO/IEC 17025:2017, ensuring technical competence and rigorous data integrity. Element acquired Clinimark in 2022 to expand its connected technologies and life sciences capabilities.
While Good Clinical Practice principles and human subject protection regulations guide study conduct, Element Boulder’s role is to generate high-quality clinical validation data to support sponsor regulatory submissions, including 510(k), De Novo, and EU MDR filings.
Medical experts, engineers, and clinical research professionals are involved from protocol development through execution and final reporting.
Compliance and capabilities at Element Boulder
Components and materials we test at this location
These are our most prevalent requests. Don't see what you're looking for? Contact us!
Medical Devices
- Pulse oximeters
- Non-invasive blood pressure monitors
- Cuffless blood pressure wearables
- Invasive blood pressure monitoring systems
- Respiratory rate monitors
- ECG/EKG monitors
- Temperature monitoring devices
- Glucose monitoring devices
- Sleep monitoring systems
- Multi-parameter patient monitors
- AI-based physiological algorithms
Wearables
- Smartwatches with health sensors
- Fitness trackers
- Health monitoring patches
- Wrist-based BP monitors
- Ring-based monitoring devices
- Chest straps
Consumer Health Electronics
- Wellness devices making clinical performance claims
- Home-use monitoring devices
- Remote patient monitoring systems
- Mobile-connected health devices
Special Testing Scenarios
- Low perfusion validation
- Hemodilution studies
- Hypoxia studies
- Motion interference testing
- Sensor-off condition testing
- Diverse skin tone validation
Standards We Test At this Locations
These are our most prevalent requests. Don't see what you're looking for? Contact us!
Core Device Validation Standards
- ISO 80601-2-61 – Pulse oximeter equipment requirements
- ISO 81060-2 – Non-invasive sphygmomanometers
- IEEE 1708 – Wearable cuffless blood pressure devices
Human Factors & Usability
- IEC 62366-1 – Usability engineering for medical devices
- FDA Human Factors Guidance
U.S. Regulatory Framework (Human Subject Protection)
- 21 CFR Part 50 – Protection of Human Subjects
- 21 CFR Part 812 – Investigational Device Exemptions
Measurement Traceability
- All critical measurement equipment is externally calibrated by accredited providers and maintains NIST-traceable calibration.
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Lab Capabilities Sheet
Global expertise
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