Noninvasive Device Testing for FDA 510(k) Submissions
Vital Signs Research Group provides comprehensive medical device testing services for manufacturers of noninvasive vital signs devices. Based in San Francisco, we conduct FDA 510(k)-aligned clinical validation studies for pulse oximeters, blood pressure monitors, heart rate monitors, respiratory rate monitors, and glucometers — handling everything from protocol design to final study report.
Our device testing services are built around your device and your timeline. Whether you’re in the early stages of development or preparing your final submission package, we design custom clinical protocols, secure IRB approval through Advarra, and recruit from a pre-screened participant database of hundreds of individuals to keep your study on schedule.
For every study, we recruit from a diverse participant pool to meet regulatory requirements for representative population distribution — ensuring inclusive, reliable results that hold up to FDA scrutiny.
Explore our individual device testing services below, or contact us to discuss a custom study for your device.
