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.
This service is offered at a rate of €175/hour, excluding VAT. The cost covers comprehensive clinical validation support, including access to a network of Test Beds and the expertise of both in-house and outsourced clinical specialists. This flexible pricing structure allows EIC beneficiaries to tailor the depth and extent of evaluations needed to achieve reliable validation and market readiness of their digital health innovations.
Our services are designed to be flexible to accommodate the unique needs and schedules of each client. As such, we do not enforce strict deadlines. We work collaboratively with our clients to establish mutually agreeable timelines that align with project goals and regulatory requirements.
Intellectual Property & Legal
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Is this the service you are looking for? If so, you can apply to the service through EIC ACCESS+! Eligible applicants can also get co-funding through the EIC ACCESS+ initiative. Find out more on the project webiste.
Receive up to €60,000 in grants, covering up to 50% of the costs, to access specialised services from the EIC Service Catalogue. Learn more on the EIC ACCESS+ website.