When planning a clinical research study intended to support an FDA submission , sponsors often encounter terms such as multi-site, multi-investigator , and single-site, multiple-location . While these models may appear operationally similar, they differ in oversight structure, execution, and how evidence is evaluated by the FDA—particularly for cuffless blood pressure devices . Understanding these distinctions is essential for aligning trial design with FDA expectations and w

Accurate oxygen saturation measurement is foundational for modern physiological monitoring, especially for developers of pulse oximeters, wearables, and multiparameter platforms. Yet many devices fail to achieve regulatory expectations because their performance is never tested across the full range of oxygen saturation levels humans experience.  Controlled desaturation studies fill this gap, ensuring claims reflect real-world performance. These studies intentionally and safel

Transparent clinical operations have become a defining differentiator for high-performing contract research organizations. Yet many medical device and wearable developers still encounter opaque decision-making, limited protocol visibility, and communication gaps that slow execution and create unnecessary regulatory friction. The result is predictable: CRO risk mitigation becomes reactive instead of proactive , and promising technologies reach the FDA or CE mark later than the

Engineering leaders developing physiological monitoring devices often encounter references to “arterial line measurements” in validation standards and technical literature. Although arterial lines are invasive and placed in clinical environments, the data they generate is central to how the industry defines accuracy for non-invasive technologies.  This article explains what an arterial line is, why its measurements are considered a benchmark, and how arterial line data is use

Engineering Reliability: What CTOs Need to Know About Regulatory-Grade Physiological Monitoring Validation   CTOs in medical-device startups face an engineering challenge that extends far beyond hardware and firmware. The success of a physiological monitoring product—whether a pulse oximeter, blood pressure monitor, or wearable sensing platform—depends on rigorous clinical research studies capable of supporting FDA and CE mark submissions. The gap between early engineering va

How PRL Ensures Data Integrity in Physiological Monitoring Research   For CTOs and technical leaders in MedTech, data integrity is not a paperwork detail—it is the backbone of regulator-ready evidence. Whether your device requires pulse oximetry testing during controlled desaturation in a hypoxia lab, multi-parameter wearables validation, or multi-site clinical research studies, every data point must be defensible. ALCOA+ provides the industry-standard framework for achieving

Sponsors often choose CROs based on price or speed, but the wrong partner can cost far more. Delayed timelines. Poor data. FDA...