BLOOD PRESSURE
We offer validation studies for the entire range of noninvasive blood pressure (NIBP) monitoring technologies from traditional cuff-based devices to innovative cuffless and wearable solutions. Our work is built on a strong foundation of both regulatory insight and technical expertise. We are versed in the requirements of ISO 81060-2 and ISO 81060-3, and we are proud to be contributing in the development of ISO 81060-7, the upcoming standard for cuffless devices. Being involved in shaping this new standard means that in addition to keeping up with industry best practices, we are also helping to define what’s next in the future of cuffless technology validation.
To ensure accuracy and data integrity, we rely on gold-standard reference methods such as invasive arterial line measurements and dual-observer auscultation. Our dedication to precision is reflected in our consistently high inter-observer reliability: analysis of our clinical trial data shows that the difference between observers stays within 4 mmHg 99.7% of the time for both systolic and diastolic readings.
PULSE OXIMETRY
We validate pulse oximeter performance through controlled desaturation studies following ISO 86010-2-61 and FDA guidance. By testing on a diverse participant cohort across oxygen saturation to levels between 100% and 70%, we verify accuracy using gold-standard co-oximetry analysis. A primary focus of our study design and participant recruitment is to ensure equitable device performance across a diverse spectrum of skin pigmentations, providing manufacturers with the robust data required for regulatory submission.
Our staff is a dedicated, multidisciplinary team of medical and research professionals committed to precision, ethics, and above all, participant safety. Our physicians, nurses, and researchers are skilled in placing and managing invasive arterial lines, drawing reference arterial blood samples, and operating co-oximetry equipment. This level of clinical expertise delivers consistent and accurate results.
OTHER VITAL SIGNS
In addition to our core expertise in blood pressure and pulse oximetry, we also provide comprehensive clinical validation for a wide range of physiological monitoring devices. Our capabilities extend to critical parameters including respiratory rate, heart rate, and pulse rate. We perform expert manual scoring and adjudication of raw physiological waveforms, including End-Tidal CO2 (ETCO2) and ECG. This meticulous annotation process provides the definitive ground truth needed for validation.
To ensure your device is robust enough for real-world use, our clinical trial recruitment is strategically targeted. We focus on enrolling populations of interest known to challenge device performance, such as Chronic Obstructive Pulmonary Disease (COPD) and Atrial Fibrillation (A-fib), allowing us to validate performance across a diverse range of physiological states.
HUMAN FACTORS
Beyond clinical accuracy, we can provide comprehensive Human Factors and Usability Testing to ensure your device is safe, effective, and intuitive for its intended users. We conduct both formative evaluations during the design process and summative validation testing on the final product.
By conducting simulated-use testing with representative users, including patients, caregivers, and clinicians, we identify critical task failures, use errors, and close calls, tracing them back to root causes in the device's design or instructions. The result is an actionable report that supports design improvements and provides the objective evidence required to demonstrate your device can be used safely and effectively by its intended users.