Our Services

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 to verify blood sample accuracy with precision and efficiency.

In addition to standard testing, we conduct motion artifact and low perfusion simulations to assess device performance under challenging conditions. Every study concludes with a detailed final report suitable for regulatory submissions, including FDA 510(k) filings, upon request.

We provide validation testing for both cuffed and cuffless blood pressure monitors in alignment with the most current ISO, IEEE, and FDA guidelines. Reference measurements can be obtained using either a manual sphygmomanometer or an arterial line, depending on study requirements.

To ensure a robust evaluation across a wide range of physiological conditions, we can safely manipulate blood pressure through isometric exercise, cold exposure, or pharmacological methods as appropriate.

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. For additional precision, we can also utilize a bench-top physiological monitor to evaluate performance across various conditions.