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Sviluppo di tecnologie e dispositivi per la salute
Abstract
UBORA (“excellence” in Swahili), a project founded by European Union, brings together European and African Institutions to create an e-infrastructure for the co-design of open source biomedical devices based on the local needs and constraints. The e-platform is aimed at stimulating innovation in the field of BME through knowledge distribution, promoting harmonization of biomedical device safety requirements and provision of standardized methods for design control. The e- infrastructure is developed by UBORA project participants, from the Academia and the Industry; technical solutions for the infrastructure and implementation of its main functionality are aimed at obtaining a simple and lightweight responsive user-interface (UI), helping users to accomplish a given task as simply and efficiently as possible. The UBORA e- infrastructure is developed to be a modern web standards compliant application available to all common devices and platforms through any web browser.
The running version of the e- infrastructure is available at http://ubora-kahawa.azurewebsites.net/. It is under continuous improvement by AgileWorks with the feedback from the UBORA partners. The infrastructure is an integrated virtual ecosystem, which will lead engineers and healthcare workers through all the phases of innovative design, fabrication, development, testing and implementation of biomedical technology. It will ensure regulatory compliance to main international standards through control of regulatory inputs and verification of regulatory outputs.
The project management UI allows following pre-defined steps in the design process. The steps have been chosen to mirror the most common design steps as described by ISO standard for quality management systems for the biomedical industry (ISO 13485:2016) and as also described in current GMPs.
This e- infrastructure enables a peer-to-peer evaluation and a subsequent expert review of the design. UBORA will lead to improvements in open design processes as it ensures higher compliance to industry standards without being a financial or temporal burden on designers. Quality and safety guidelines for biomedical devices, under the guidance of ISO standards and current European Medical Device Regulation, are the cornerstones of the project. The e-infrastructure will be spread to other institutions through partnerships and linkages embedded in the e-platform’s architecture.
Autori
Licia Di Pietro research center e. piaggio and dpt of ingegneria dell’informazione of university of pisa pisa italy
Alice Ravizza bioindustry park silvano fumero torino italy
Andres Diaz Lantada universidad politécnica de madrid madrid spain
Kädi Avik agileworks tallin estonia
Philippa Makobore uganda industrial research institute kampala uganda
Carmelo De Maria research center e. piaggio and dpt of ingegneria dell’informazione of university of pisa pisa italy
Arti Ahluwalia research center e. piaggio and dpt of ingegneria dell’informazione of university of pisa pisa italy
