CORDIS Project
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HEU-EFS aims to create a standardized framework for early feasibility studies of medical devices in the EU. It focuses on engaging stakeholders to enhance clinical evidence generation and improve the development process of medical technologies.
EU Regulations on medical devices (MDs), in-vitro diagnostics, and Health Technology Assessment envisage a harmonised lifecycle approach for clinical evidence generation of MDs.
To be effective this approach requires evidence generation plan to be developed since early stages of product development, by engaging all relevant stakeholders.At present, in the EU there are no standardized procedural frameworks/guidelines/common reference standards for Early Feasibility Studies (EFS), clinical investi…
UNIVERSITA COMMERCIALE LUIGI BOCCONI
Partner organizations (coordinator is shown above), with normalized type and CORDIS activity type. Guests see up to 4 partners.
Spain, Barcelona
Type: Research institute
Activity type: Research Organisations
SME: No
Italy, Roma
Type: Public body
Activity type: Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
SME: No
ASSISTANCE PUBLIQUE HOPITAUX DE PARIS
France, Paris
Type: Research institute
Activity type: Research Organisations
SME: No
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