Data-Driven Medical Devices and the EU MDR: Mapping Gaps in Standards for Regulatory Compliance

dc.contributor.author Epiphaniou, Gregory
dc.contributor.author Harrison, Stuart
dc.contributor.author Khadka, Anita
dc.contributor.author Maple, Carsten
dc.contributor.author Matragkas, Nikolaos
dc.contributor.author Islam, Saif Ul
dc.contributor.author Atmaca, Ugur Ilker
dc.date.accessioned 2026-04-21T10:55:40Z
dc.date.available 2026-04-21T10:55:40Z
dc.date.issued 2026-03-09
dc.description.sponsorship This work is co-funded by the HORIZON.2.1 - Health Programme of the European Commission, Grant Agreement number: 101095661 - Innovative applications of assessment and assurance of data and synthetic data for regulatory decision support (INSAFEDARE). The authors declare no competing financial or non-financial interests.
dc.description.sponsorship European Commission, EU, (101095661)
dc.description.sponsorship European Commission, EU, (101095661); European Commission, EU
dc.identifier.doi 10.1038/s44401-026-00075-2
dc.identifier.issn 3005-1959
dc.identifier.scopus 2-s2.0-105033662462
dc.identifier.uri https://hdl.handle.net/20.500.12573/5910
dc.identifier.uri https://doi.org/10.1038/s44401-026-00075-2
dc.language.iso en
dc.publisher Springer Nature
dc.relation.ispartof Npj Health Systems
dc.rights info:eu-repo/semantics/openAccess
dc.title Data-Driven Medical Devices and the EU MDR: Mapping Gaps in Standards for Regulatory Compliance en_US
dc.type Article
dspace.entity.type Publication
gdc.author.scopusid 57211019950
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gdc.author.scopusid 7402647619
gdc.coar.access open access
gdc.coar.type text::journal::journal article
gdc.collaboration.industrial false
gdc.description.department Abdullah Gül University
gdc.description.departmenttemp [Atmaca U.I.] WMG, University of Warwick, Coventry, United Kingdom, Abdullah Gul University, Kayseri, Turkey; [Islam S.U.] WMG, University of Warwick, Coventry, United Kingdom; [Epiphaniou G.] WMG, University of Warwick, Coventry, United Kingdom; [Khadka A.] WMG, University of Warwick, Coventry, United Kingdom; [Harrison S.] WMG, University of Warwick, Coventry, United Kingdom; [Matragkas N.] CEA, List, Université Paris-Saclay, 2 Bd Thomas Gobert, Palaiseau, France; [Hansen S.] The Open Group, Brussels, Belgium; [DeLong R.] The Open Group, Brussels, Belgium; [Maple C.] WMG, University of Warwick, Coventry, United Kingdom, The Alan Turing Institute, London, United Kingdom
gdc.description.issue 1
gdc.description.publicationcategory Makale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanı
gdc.description.volume 3
gdc.identifier.openalex W7134282342
gdc.index.type Scopus
gdc.openalex.collaboration International
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