About Element Boulder
Compliance and capabilities at Element Boulder
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
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.
Download
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.
Global expertise
Working with Element, you have access to our global network of materials testing and product qualification test experts. Meet our Engaged Experts.
But don't just take our word for it
See what others have to say about partnering with Element