UBORA

UBORA is an e-infrastructure for the co-design of open source medical devices, which promotes compliance with internationally recognized quality standards and regulations for safety and efficacy of devices, taking the EN ISO 13485:2016 and the MDR 2017/745 as inspiration. UBORA guides the user through a systematic design process, from the identification of clinical needs, of risks class and relevant standards for the device, and provides a project management tool, including a repository, finalized to the preparation of the pre-production device dossier. The entire process is supervised by expert mentors, which ensure that safety and efficacy criteria are fulfilled. The e-infrastructure is organized in 3 main sections: The “Clinical Needs” section is aimed at identifying bioengineering design specifications linked to a particular clinical need. It provides a unique environment for healthy discussions between patients, healthcare providers and engineers, to ensure that clinical needs are turned into safe and affordable projects. The “Project management” section is opened to users to design medical devices (MD) under the coordination of expert mentors. It is a MD oriented project management environment, including a repository, available for free download of project blueprints which have completed the development and compliance phase. This section provides a meta-structure composed of 6 Work Packages inspired by the EN ISO 13485 and tools for automatic risk class classification and ISO standards identification. The resource section contains a selected teaching/learning material on biomedical engineering, as well as the documentation and tutorials to use and further develop the e-infrastructure. The UBORA e-infrastructure is thus a tool for promoting and strengthening the initiatives of an international community of designers, healthcare providers and policy-makers, toward the reduction of inequalities in the access to MD. If properly implemented, these open source MD can be considered in line with the MDR 2017/745 from the design point of view: in a nutshell, its final aim is to promote the well-being for all, moving towards health equity in accordance with the United Nations Sustainable Development Goals.