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Challenges Associated with the Safety Signal Detection Process for Medical Devices

BACKGROUND: Previous safety issues involving medical devices have stressed the need for better safety signal detection. Various European Union (EU) national competent authorities have started to focus on strengthening the analysis of vigilance data. Consequently, article 90 of the new EU regulation...

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Detalles Bibliográficos
Autores principales:	Pane, Josep, Verhamme, Katia M C, Villegas, Dorian, Gamez, Laura, Rebollo, Irene, Sturkenboom, Miriam C J M
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	Dove 2021
Materias:	Review
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7917351/ https://www.ncbi.nlm.nih.gov/pubmed/33658868 http://dx.doi.org/10.2147/MDER.S278868

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