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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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Bibliografski detalji
Izdano u:Med Devices (Auckl)
Glavni autori: Pane, Josep, Verhamme, Katia M C, Villegas, Dorian, Gamez, Laura, Rebollo, Irene, Sturkenboom, Miriam C J M
Format: Artigo
Jezik:Inglês
Izdano: Dove 2021
Teme:
Online pristup: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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