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The UBORA E-Infrast...
The UBORA E-Infrastructure for Open Source Innovation in Medical Technology
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De Maria, C. (author)
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Di Pietro, L. (author)
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Lantada, A. D. (author)
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Ravizza, A. (author)
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- Mridha, Mannan (author)
- KTH,Hälsoinformatik och logistik
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Torop, J. (author)
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Madete, J. (author)
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Makobore, P. (author)
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Ahluwalia, A. (author)
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(creator_code:org_t)
- 2019-09-25
- 2020
- English.
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In: XV Mediterranean Conference on Medical and Biological Engineering and Computing – MEDICON 2019. - Cham : Springer. ; , s. 878-882
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https://arpi.unipi.i...
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
Subject headings
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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.
Subject headings
- NATURVETENSKAP -- Data- och informationsvetenskap (hsv//swe)
- NATURAL SCIENCES -- Computer and Information Sciences (hsv//eng)
Keyword
- E-infrastructure
- Open source medical devices
- Regulation
- Safety
Publication and Content Type
- ref (subject category)
- kon (subject category)
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