We provide validation testing for cuffed blood pressure monitors following ISO 81060-2 and FDA guidance. Reference measurements can be obtained using either a manual sphygmomanometer or an arterial line, depending on sponsor requirements.
We can also test continuous noninvasive blood pressure monitors. The results of these tests can be used for development purposes or can be submitted to the FDA in support of a 510 (k) submission.
In our experience, the FDA generally expects blood pressure changes for clinical trials involving continuous noninvasive blood pressure monitor. We have several protocols to safely increase and decrease the subject’s blood pressure for this type of testing.
For a standard 85 subject cuffed test, we require about 100 subjects to be enrolled to meet ISO 81060-2 blood pressure stratification requirements. Generally, we schedule up to 15 subjects per day. During this testing, we can record the manual sphygmomanometer pressure and stethoscope heart sounds for review after the study. We can test children as young as 3 years old if you are trying to make a pediatric claim. We can also test infant size cuffs in babies in hospitals around the bay area.
Please contact us about protocols that we have for continuous blood monitors that meet FDA testing requirements.
Cuffed & Cuffless Blood Pressure Monitor Studies
At Vital Signs Research Group, we conduct comprehensive blood pressure testing and validation studies at our San Francisco facility, supporting manufacturers of both cuffed and cuffless devices through the FDA 510(k) clearance process.
Our team designs and executes clinical studies tailored to your specific device, whether you’re developing an upper-arm cuff monitor, a wrist device, or a next-generation cuffless continuous monitor. We bring the clinical infrastructure, participant recruitment network, and regulatory expertise to move your study forward without delay.
Our blood pressure validation studies are conducted in alignment with AAMI/ISO 81060-2 and relevant FDA guidance for non-significant risk devices. Each study is reviewed and approved and is conducted in full compliance with ISO 14155, FDA 21 CFR 50, and FDA 21 CFR 812.
We handle participant recruitment from our pre-screened database, ensuring the diverse population distribution required for a regulatory submission. Our registered nurses and clinical research coordinators manage every aspect of the study day — from participant intake to data collection and protocol compliance.
Our blood pressure testing process covers monitoring protocols as applicable, paired measurement comparison with validated reference devices, diverse participant recruitment meeting regulatory distribution requirements, full documentation and a clinical report formatted for FDA submission for every study. (confirm with client: specific protocols offered for cuffless continuous monitors)
Whether you’re a startup preparing your first submission or an established manufacturer validating a next-generation device, we’ll design a clinical protocol built around your needs.
Reach out to Vital Signs Research Group to start your blood pressure validation study — let’s turn your innovation into impact.