Cuffed & Cuffless Blood Pressure Monitor Studies
Blood pressure monitors are among the most widely used medical devices in the world — and among the most rigorously regulated. 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 by our external Institutional Review Board (Advarra) 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 credible 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 both static and ambulatory 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, and IRB oversight through Advarra 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.