Blood Pressure Monitor Clinical Validation Testing

Element validates blood pressure monitoring devices used across healthcare and consumer settings. Our testing capabilities cover the full spectrum from medical-grade equipment to smart devices and wearables. We specialize in both traditional automated monitors and emerging technologies like cuffless blood pressure devices integrated into consumer electronics.

We deliver comprehensive validation testing tailored to your device specifications. Our testing encompasses invasive arterial monitoring at 100Hz frequency and non-invasive dual auscultation assessments. with specialized testing across a range of hypertension levels, body mass ranges, and age groups. Our protocols specifically track blood pressure changes as required by regulatory bodies to verify device accuracy across varied conditions.

Our turnkey approach streamlines your entire validation process from start to finish. We manage protocol design, IRB oversight, participant recruitment, and data analysis. We help you decipher complex study parameters and requirements through our active participation in the development of current standards. Our proprietary methods for blood pressure change induction accelerate data collection while maintaining rigorous compliance with all regulatory requirements.

Regulatory bodies require testing to verify a device’s ability to detect blood pressure changes. Element’s proprietary methods for inducing blood pressure changes ensure straightforward data collection across a variety of participants.

• For invasive data collection, we record arterial blood pressure waveforms and digital pressures at 100Hz. These waveforms and raw data are available upon request, along with other engineering data for development or final reports.
• For non-invasive data collection (dual auscultation), we compare data to our proprietary NIST-traceable digital reference sphygmomanometers. These offer more accurate reference measurements than traditional mercury manometers by eliminating common inaccuracies and providing visual and digital reference measurements. 

Our testing infrastructure features proprietary NIST-traceable digital reference sphygmomanometers that deliver superior accuracy compared to traditional mercury manometers. High-frequency arterial monitoring systems capture detailed waveform data at 100Hz, providing comprehensive insights for development and validation.

Element Boulder specializes in clinical validation testing for medical devices and wearables.  For more than three decades, we have proudly served as the premier clinical testing and regulatory validation partner to the medical device, wearables and consumer electronic industries.

We understand that the study parameters and requirements are not always easy to decipher. Our staff are members of the ISO and IEEE blood pressure committees and are actively involved in the development of current standards. When drafting your protocols, the process is simplified with our help, and our experienced consultants can also help you set up a successful study for FDA and other regulatory submissions.