Clinical Investigation and Testing Support

This service provides a structured approach to clinical validation for software and AI-based medical devices, specifically designed to support digital health companies and innovators. The service aims to verify product usability and performance within real-world settings through access to a network of Hospitals in our Test Beds. The service’s duration is 4 months and is divided into three phases. The pre-assessment phase tailors evaluation criteria specific to the device's requirements, establishing usability metrics. The testing phase entails direct usability assessments and trials within designated Test Beds, ensuring rigorous evaluation under realistic conditions. These activities are conducted by in-house clinical specialists and outsourced partners, providing comprehensive insights into device functionality and safety. The final analysis phase consolidates results into a detailed validation report, outlining any improvements needed and confirming market readiness. The primary outcome is a thoroughly validated product, equipped for competitive entry into the market. Implementation involves a fully remote support, allowing for timely adjustments and optimised results based on emerging data.By delivering these services, Complear empowers healthcare innovators to achieve reliable clinical validation, enhance device usability, and ensure compliance with industry standards, ultimately facilitating successful product deployment in healthcare settings.