About
Vital Signs Research Group is located in the San Fransisco Bay Area. We specialize in testing noninvasive continuous blood pressure monitors, pulse oximeters, respiratory rate monitors, and heart rate monitors.
If you want to develop your own clinical protocol to test your medical device, our team of physicians can work with you to develop a streamlined protocol to test medical devices following all applicable FDA and ISO standards. Once a protocol is developed, we will work with an IRB to approve it.
Our team of Anesthesiologists and clinical research coordinators has many years of clinical research experience, and we can overcome many recruitment challenges. We have a database of hundreds of subjects to meet the regulatory requirements for testing.
Regulatory
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.