The UBORA E-Infrastructure for Open Source Innovation in Medical Technology
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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.
KeywordsOpen source medical devices E-infrastructure Safety Regulation
This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement N° 731053. The authors acknowledge all students and mentors who daily animate the UBORA e-infrastructure.
Conflict of Interest.
The authors have no conflict of interest to disclose.
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