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The need for action by evaluators and decision makers in Europe to ensure safe use of medical software

Digital Health Solutions (DHS) approved under the Medical Device Directive (MDD) in the European Union may be used until May 27, 2025. The regulation provides appropriate requirements for the products but lack the evaluation by an external independent organization. For many DHS, the company can make...

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Detalles Bibliográficos
Autor principal: Kyhlstedt, Mattias
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9745019/
https://www.ncbi.nlm.nih.gov/pubmed/36523427
http://dx.doi.org/10.3389/fmedt.2022.1063622