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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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| Publicat a: | Med Devices (Auckl) |
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| Autors principals: | , , , , , |
| Format: | Artigo |
| Idioma: | Inglês |
| Publicat: |
Dove
2021
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| Matèries: | |
| Accés en línia: | 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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