Our Services

For every study, we recruit from a diverse participant pool to meet regulatory requirements for representative population distribution and ensure inclusive, reliable results.

  • We offer comprehensive calibration and validation testing for pulse oximeters in accordance with ISO 80601-2-61 and applicable FDA guidance. Our lab currently utilizes three Radiometer ABL90 analyzers. Due to changing testing requirements we recommend testing at least 24 subjects with at least 25% being considered dark skinned (MST 8-10). We can test up to 8 subject per day.

    In addition to standard hypoxia testing, we can also test pulse oximeters under various conditions such as motion testing, low perfusion testing, increased carboxyhemoglobin, increased methemoglobin and low hemoglobin.

    Every study concludes with a detailed final report suitable for regulatory submissions, i.e FDA 510(k) submissions.

  • We provide validation testing for both cuffed blood pressure monitors following ISO 81060-2 and FDA guidelines. Reference measurements can be obtained using either a manual sphygmomanometer or an arterial line, depending on study requirements.

    We can also test continuous noninvasive blood pressure monitors. The results of these tests can be used for developing your device or can be submitted to the FDA in support of a 510 (k) submission.

    In our experience the FDA generally wants to see blood pressure changes during continous noninvasive blood pressure monitor testing. We have a number of protocols to safely increase and decrease subject’s blood pressure for this type of testing.

  • Respiratory rate testing can be performed as a standalone study or integrated into any of our existing test protocols. We use a GE Anesthesia Monitor as the primary reference device, and can also utilize raw capnography data from our gas analyzer for precise, high-resolution measurements.

  • We offer heart rate monitor accuracy testing as either a standalone service or as part of a broader pulse oximetry validation protocol. When tested independently, we perform comparative in vivo analyses using FDA-cleared heart rate monitors as reference devices. Increasingly, we have seen the FDA requiring in-vivo testing for wearable devices.

  • We can perform Glucometer testing following FDA guidances.