CE Accreditation and Barriers to CE Marking of Pediatric Drug Calculators for Mobile Devices: Scoping Review and Qualitative Analysis

BACKGROUND: Pediatric drug calculators (PDCs) intended for clinical use qualify as medical devices under the Medical Device Directive and the Medical Device Regulation. The extent to which they comply with European standards on quality and safety is unknown. OBJECTIVE: This study determines the numb...

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Detalles Bibliográficos
Autores principales: Koldeweij, Charlotte, Clarke, Jonathan, Nijman, Joppe, Feather, Calandra, de Wildt, Saskia N, Appelbaum, Nicholas
Formato: Online Artículo Texto
Lenguaje:English
Publicado: JMIR Publications 2021
Materias:
Review
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8713103/
https://www.ncbi.nlm.nih.gov/pubmed/34898456
http://dx.doi.org/10.2196/31333

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8713103/
https://www.ncbi.nlm.nih.gov/pubmed/34898456
http://dx.doi.org/10.2196/31333

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