Welcome to Resources, where we will put up helpful files and documentation.
Overview of UBORA e-infrastructure
UBORA is an e-infrastructure which promotes and sustain the development of open source medical devices, providing a structured framework for the identification of clinical needs, risk class, relevant standards, management of computer-aided modeling files, and preparation of the pre-production device dossier. Each stage is vetted and monitored by experts to ensure that safety criteria, inspired by EU Medical Device Regulation 2017/745, are met during the design process.
The e-infrastructure is organized by 3 main sections:
- Clinical needs: aimed at identifying bioengineering solution linked to specific clinical needs. To create safety and impactful medical solutions, this section provides an environment for healthy discussion between patients, healthcare providers and engineers to ensure that are turned into projects.
- Project management: · a guided design process for supporting researchers in the standard-oriented design of medical devices with specific features for identifying risk class and relevant applicable standards; it includes also a repository for file sharing, and ends with a section that prepares the project for fund raising;.
- Resource section: with selected teaching/learning materials on BME.
Joining UBORA means being part a community of developers, including professional engineers and healthcare providers, aimed at designing new open source solutions for current and future healthcare challenges, for a larger access to medical devices.