ISO 14155 & FDA-Compliant Study Design
Vital Signs Research Group is a medical device CRO based in the heart of the San Francisco Bay Area. We specialize in designing and executing custom clinical protocols for noninvasive vital signs devices — helping innovators validate their technology and build the evidence needed for FDA 510(k) submissions.
We test continuous blood pressure monitors, pulse oximeters, respiratory rate monitors, heart rate monitors, and glucometers. Whether you’re in the early stages of development or finalizing your submission package, we work with you to design a clinical protocol tailored to your device, your timeline, and your regulatory pathway.
Our team of experienced physicians and clinical researchers ensures all testing aligns with current FDA and ISO guidelines. We work closely with our IRB to secure necessary approvals quickly and efficiently, and we bring over a decade of hands-on research expertise to every engagement.
Our extensive subject database includes hundreds of pre-screened participants — giving us the flexibility to navigate even the toughest recruitment challenges and keep your study on schedule.
Let’s turn your innovation into impact, one data point at a time.
We adhere to ISO 14155, FDA 21 CFR 50, and FDA 21 CFR 812 for all our studies. Each study undergoes review and approval by an external Institutional Review Board (IRB), specifically Advarra. All of our research team members are regularly trained in Good Clinical Practice (GCP) and Human Subject Protection (HSP) and hold training certificates. We can provide relevant documentation, as required, during the study initiation phase to ensure full compliance with ISO 14155.