About Element Boulder
Element Boulder is an end-to-end Clinical Research Organization (CRO) specializing in clinical validation studies for connected health, wearable, and medical technologies. The site designs and executes IRB-approved clinical trials and validation protocols to generate high-quality evidence supporting regulatory submissions, including FDA 510(k), De Novo, and EU MDR pathways.
The facility located on the AdventHealth Avista hospital campus was procured through Element’s acquisition of Clinimark in 2022. Its partnership with a broad network of hospital and research partners provides access to diverse study populations, geographically diverse dedicated clinical research laboratories, and a wide variety of advanced physiological monitoring capabilities to enable execution of both single-site and multi-site clinical validation programs.
Element Boulder operates under a quality management framework aligned with ISO 14155:2026 and Good Clinical Practice (GCP) principles, ensuring the protection of study participants and the integrity of clinical data throughout the research program.
The organization is also an active contributor to the advancement of global medical device standards. Team members serve on the ISO committees responsible for ISO 81060-2 and ISO 80601-2-61, contributing clinical data, technical expertise, and scientific rationale that help shape revisions and guide future requirements for device validation and performance assessment.
Compliance and capabilities at Element Boulder
Components and materials we test at this locatio
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 & consumer health electronics including SaMD
Special Testing Scenarios
- Low perfusion validation
- Hemodilution studies
- Hypoxia studies
- Motion interference testing
- Sensor-off condition testing
- Diverse skin tone validation
End to End Study Lifecycle Support
- Protocol development & collaboration
- IRB submission & management
- Study setup
- Study execution
- Post study data management
- Data review and final report
- Monitoring
- Study design
- Consulting
- Participant recruitment
Standards We Test At this Location
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
Clinical Trials at Element Boulder
To support our customers and sponsors in delivering the clinical research studies from Element Boulder, our internal team of recruiters helps attract and source the required participant demographics and numbers that make your trials possible. From blood pressure cuffs, respiratory devices, smart watches, and pulse oximeters, we help power the research before it reaches FDA approval.
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