Project description
Novel toolkit for dataset assessment and assurance
The significant volume of data generated since the digital transition has highlighted the necessity for data assurance and verification, particularly in the context of decision-making. Despite this pressing need, there is a notable absence of tools tailored to meet this demand. The EU-funded INSAFEDARE project aims to address this gap by creating an innovative toolkit. This toolkit will grant decision-makers access to efficient tools that assess, assure, and validate datasets at a reduced cost. Additionally, the project will explore synthetic datasets to enhance certification processes and mitigate risks for stakeholders, regulatory bodies, and developers. Ultimately, the project aims to provide a tool capable of monitoring, integrating, and combining multiple datasets for time-efficient assessments.
Objective
INSAFEDARE aims to provide a toolkit to enable cost-effective and high assurance decision-making in the context of the processes that all stakeholders may follow as part of regulation of medical devices. The toolkit consists of scientific guidance on assurance, tools to retrieve datasets and assist application validation and a publicly available guidance work-group for sustainable support of the discipline. INSAFEDARE will investigate use, challenges, and opportunities real world and synthetic data-driven validation of devices. The project will provide guidance on quality and safety assurance of datasets as a tool for validation, and devices that have validated using data driven approaches. INSAFEDARE will investigate use of synthetic datasets and will identify how they can be used to establish assurance before the formal, established certification process, reducing the risk for developers and waste for regulatory bodies. Furthermore, the project will publish the findings as a public guidance, laying the ground for a standard development working group; and develop training and syllabus that can enhance the skills of stakeholders. Finally, the project will develop a tool for the discovery, integration, and query of multiple datasets, and a tool for supporting the sustainable, dynamic, and through-life surveillance of devices, capturing the impact of new evidence offered by newly published datasets.
Fields of science
Programme(s)
Funding Scheme
HORIZON-RIA - HORIZON Research and Innovation ActionsCoordinator
75015 PARIS 15
France