Our Services

For all our studies, we recruit from a diverse subject pool to ensure compliance with regulatory requirements regarding subject population distributions.

  • We can test pulse oximeters for calibration and validation following ISO 80601-2-61 and FDA guidance documents. Currently we are using 3 Radiometer ABL90s to verify the accuracy of blood samples. We can also perform motion testing and low perfusion testing. All testing includes a final report for regulatory submissions, if needed.

  • We can test cuffed and cuffless blood pressure monitors following the latest guidance from the ISO, IEEE and the FDA. We can use an arterial line or a manual sphygmomanometer as a reference. We can also manipulate blood pressure during testing using isometric exercise, cold exposure or pharmacologically.

  • Respiratory rate testing can be done as an addition to any one of our tests or on its own. We use a GE Anesthesia Monitor as a reference device or we can use raw capnography from our gas analyzer.

  • We can test heart rate monitor accuracy as an addition to pulse oximetry testing or on its own. When examining heart rate monitors on their own, we can conduct comparative analyses against FDA-approved heart rate monitors in vivo. We can also use a bench top monitor to determine its accuracy.