Why ISO 81060-2 Matters for Accurate Blood Pressure Monitoring   Non-invasive blood pressure devices must demonstrate dependable performance before developers can advance toward FDA or CE mark submissions. ISO 81060-2  “Non-invasive sphygmomanometers — Part 2: Clinical investigation of intermittent automated measurement type ” sets a clear bar for clinical validation—defining study methods, reference comparisons, subject distribution, cuff/arm-size coverage, and prespecified

Introduction: Verification Defines Trust in Pulse Oximetry Pulse oximeters are among the most widely used physiological monitoring devices—found in hospitals worldwide. Yet, behind every reliable SpO₂ reading lies a complex scientific process: verification against reference standards . Pulse oximeter verification studies (or pivotal studies) confirm how closely a device’s functional oxygen saturation (SpO₂) values align with the true arterial oxygen saturation (SaO₂), measure

When preparing for a regulatory-grade validation study, the temptation is often to move quickly into execution. However, a carefully...

Why Arterial Line Monitoring Matters in Research   When evaluating new medical devices—particularly those designed for physiological...

PRL research staff performing synchronized data collection at multiple sites to ensure consistent, FDA-compliant results. Why Multi-Site...