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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Shranjeno v:
Bibliografske podrobnosti
izdano v:Med Devices (Auckl)
Main Authors: 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:
Review
Online dostop: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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