Clinical Validation Testing

Our validation studies support your entire product lifecycle, covering pulse oximetry, blood pressure, temperature monitoring, respiratory rate, ECG, heart rate variability, sleep studies, cardiac output, EtCO2, and hemodynamic monitoring. With medical technology moving toward in-home monitoring, we validate the full spectrum of monitoring technologes from clinical-grade equipment to consumer wearables.

Your comprehensive validation package includes protocol design, IRB submission management, subject recruitment and compensation, data collection, and regulatory submission preparation. We deliver both formative and summative validation testing, with specialized expertise in human factors evaluation for clinical and home environments.

Our tests include:

• Blood Pressure Monitor Clinical Validation
• Respiratory Rate Monitor Validation Testing
• Temperature Monitoring Device Clinical Validation
• Pulse Oximetry Validation
• Heart Rate Monitor Device Validation
• Sleep Monitoring Device Validation
• Consumer Devices and Wellness Products
• Human Factors Testing

Real-world clinical testing combines with expert data analysis to optimize your device performance. Our staff specialists, including anesthesiologists, pulmonologists, and cardiologists, guide protocol development and execution, identifying opportunities for improvement throughout your development cycle. Real-time data collection enables your engineers to optimize and adjust algorithms based on actual user interaction.

• Blood Pressure Monitor Clinical Validation – Invasive arterial and non-invasive blood pressure testing follows the requirements of the current version of ISO 81060-2 and IEEE 1708, as well as the FDA consensus standard for blood pressure to the extent of recognition.
• Respiratory Rate Monitor Validation Testing – Respiratory rate accuracy performance of the test monitor is evaluated in highly controlled conditions over a range of respiratory rates in specific demographics.
• Temperature Monitoring Device Clinical Validation – Establish and execute a clear study plan for temperature monitor device validation testing.
• Pulse Oximetry Validation – Under highly controlled conditions, a test pulse oximeter will be evaluated for SpO2 accuracy performance over the specified range of oxygen saturation.
• Heart Rate Monitor Device Validation – Meet regulatory requirements for accuracy testing of heart rate monitoring devices with FDA-cleared ECG simulator or FDA-cleared ECG monitor human validation testing.
• Sleep Monitoring Device Validation - Ensure the safety of devices used in sleep studies to diagnose common sleep disorders.
• Consumer Devices and Wellness Products - Ensure user safety and support marketing claims for health monitoring devices sold as consumer products or consumer devices with certification, clinical validation, and usability testing.
• Human Factors Testing - Place devices in the hands of the user in a clinical or home environment to simulate actual use and discover any risks associated with use.

Access our full equipped primary laboratory at the Avista Hospital Medical campus near Denver, Colorado, plus our extensive network of medical centers and hospital research partners nationwide. This strategic positioning provides immediate access to clinical environments and diverse patient populations.

For more than three decades, our recognized industry experts guide your entire validation journey, from protocol development through successful submission. Get direct support during regulatory discussions and benefit from authors of multiple monitoring equipment guidance documents shaping your validation strategy.