The IDIBELL Business Development and Innovation Area participates in the UMBRELLA project, a European consortium of more than 20 partners from the public and private sectors to address the stroke care process from diagnosis, prevention, episode care and rehabilitation. The project has been funded by the Innovative Health Initiative (IHI), a collaboration between Horizon Europe of the European Union and industrial associations, with 27 million euros over five years.
IDIBELL participates in UMBRELLA as a collaborating center of EATRIS, the European infrastructure for translational medicine, in its role as Expert Center for EATRIS. Thus, the role of the Business Development and Innovation Area in the project will be to provide advisory services on strategy and regulatory execution to all clinical and technological partners during the life of the project.
Legal and regulatory aspects in the development of medical devices are key to bringing solutions to the market and, therefore, to the attention of patients and the general public, and it is essential to incorporate them from the initial stages of development. To emphasize the relevance of regulation to the project’s research staff, Dr. Miguel Ángel Souto, head of the Business Development and Innovation Area at IDIBELL, gave a workshop on regulatory aspects during the kick-off meeting of the UMBRELLA project. The session focused on the requirements to be considered in the project’s conception phase, such as the purpose of use, classification, the conformity assessment route or the documentation necessary to obtain the CE marking.
The Bellvitge Biomedical Research Institute (IDIBELL) is a biomedical research center created in 2004. It is participated by the Bellvitge University Hospital and the Viladecans Hospital of the Catalan Institute of Health, the Catalan Institute of Oncology, the University of Barcelona and the City Council of L’Hospitalet de Llobregat.
IDIBELL is a member of the Campus of International Excellence of the University of Barcelona HUBc and is part of the CERCA institution of the Generalitat de Catalunya. In 2009 it became one of the first five Spanish research centers accredited as a health research institute by the Carlos III Health Institute. In addition, it is part of the “HR Excellence in Research” program of the European Union and is a member of EATRIS and REGIC. Since 2018, IDIBELL has been an Accredited Center of the AECC Scientific Foundation (FCAECC).