ThrombUS+ D6.2:Testing methodology and test plan

Deliverable D6.2, outlines the comprehensive testing methodology and detailed test plan for the ThrombUS+ system. It serves as a critical framework for demonstrating that the system aligns with identified requirements. The deliverable specifically focuses on two crucial pre-clinical testing phases: System Integration Testing and System Readiness Testing.System Integration Testing involves evaluating the functionality and interaction of the ThrombUS+ system's seven modules: the Central Hub & Intelligence (CHI), Ultrasound Monitoring (USM), Wearable Actuator (WAM), Electrical Impedance (EIM), Light Rheography (LRM), Limb Activity (LAM), and Extended Reality and Serious Gaming (XGM). This phase validates the device's four functional working methods for DVT monitoring and prevention by testing high-level workflows and module interactions at both hardware and software levels. Test cases are designed to evaluate specific system requirements, ensuring successful integration and proper functioning of components.System Readiness Testing involves comprehensive evaluation of the entire integrated ThrombUS+ device using the Central Hub & Intelligence unit, replicating real-world working modes. Beyond functional requirements, this phase rigorously assesses user safety, information security, data privacy, connection stability, and overall system robustness and reliability. Successful completion of these tests signifies that the system meets all user and system requirements, is safe and reliable, and is ready for progression to human clinical trials.Performance indicators are defined by the successful achievement of expected outcomes for each "Test Case." Any testing failures are subject to a systematic Root Cause Analysis (RCA) to identify sources of error and implement corrective actions. This ensures device safety and regulatory compliance.The comprehensive pre-clinical testing outlined in this document is essential for generating data to support progression to human clinical trials and ultimately securing regulatory review and approval.