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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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Detalhes bibliográficos
Publicado no:Med Devices (Auckl)
Main Authors: Pane, Josep, Verhamme, Katia M C, Villegas, Dorian, Gamez, Laura, Rebollo, Irene, Sturkenboom, Miriam C J M
Formato: Artigo
Idioma:Inglês
Publicado em: Dove 2021
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC7917351/
https://ncbi.nlm.nih.gov/pubmed/33658868
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.2147/MDER.S278868
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