INSAFEDARE
Financiado
INNOVATIVE APPLICATIONS OF ASSESSMENT AND ASSURANCE OF DATA AND SYNTHETIC DATA F...
INNOVATIVE APPLICATIONS OF ASSESSMENT AND ASSURANCE OF DATA AND SYNTHETIC DATA FOR REGULATORY DECISION SUPPORT
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 sc...
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.
ver más
Duración del proyecto: 35 meses
Fecha Inicio: 2023-11-01
Fecha Fin: 2026-10-31
Fecha Fin: 2026-10-31
Línea de financiación: concedida
El organismo HORIZON EUROPE notifico la concesión del proyecto el día 2023-11-01
Línea de financiación objetivo
El proyecto se financió a través de la siguiente ayuda:
Presupuesto
El presupuesto total del proyecto asciende a
3M€
Líder del proyecto
COMMISSARIAT A L ENERGIE ATOMIQUE ET AUX ENER...
No se ha especificado una descripción o un objeto social para esta compañía.
Perfil tecnológico
TRL
4-5
Perfil tecnológico
TRL
4-5