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: Inclusion Begins with Ethical Engagement   In clinical research, the term “vulnerable populations” describes individuals who may be at risk of coercion, manipulation, or harm due to limited autonomy, health literacy, socioeconomic disadvantage, or institutional dependence. Examples include individuals with cognitive limitations, students or employees under authority, people with limited language proficiency, or those experiencing social or economic marginalizat

For medical device and wearable technology developers, the success of a clinical research study often hinges on one factor: the quality...

Why the Participant Experience Matters to Sponsors   For sponsors developing wearable medical devices, every detail of a clinical...

“Our IRB Specialist managing an IRB submission for a wearable medical device study.” Introduction: Why IRB Management Is Critical for...