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Medical-device recalls in the UK and the device-regulation process: retrospective review of safety notices and alerts

BACKGROUND: Medical devices are used widely for virtually every disease and condition. Although devices are subject to regulation, the number of recalls, the clinical data requirements for regulation and the impact on patient safety are poorly understood. METHODS: The authors defined a device using...

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Detalhes bibliográficos
Main Authors: Heneghan, C, Thompson, M, Billingsley, M, Cohen, D
Formato: Artigo
Idioma:Inglês
Publicado em: BMJ Group 2011
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC3191575/
https://ncbi.nlm.nih.gov/pubmed/22021778
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1136/bmjopen-2011-000155
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