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- De Maria, C., et al.
(författare)
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The UBORA E-Infrastructure for Open Source Innovation in Medical Technology
- 2020
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Ingår i: XV Mediterranean Conference on Medical and Biological Engineering and Computing – MEDICON 2019. - Cham : Springer. ; , s. 878-882
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Konferensbidrag (refereegranskat)abstract
- The development of medical devices with open source and collaborative design methodologies has the potential to increase the access to medical technologies, thanks to a feasible reduction of design, management, maintenance, and repairing costs linked to the open access of device blueprints. UBORA is an e-infrastructure for the co-design of open source medical devices, which promotes the compliance with internationally recognized quality standards and regulations for safety and efficacy of devices, taking the EN ISO 13485:2016 and the EU 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 project management tools, including a repository, finalized to the preparation of the pre-production device dossier. The process is supervised by expert mentors, which ensure that safety and efficacy criteria are fulfilled. The UBORA e-infrastructure is in line with the 2030 Agenda for the Sustainable Development Goals, 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 medical devices.
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