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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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Autors principals: Heneghan, C, Thompson, M, Billingsley, M, Cohen, D
Format: Artigo
Idioma:Inglês
Publicat: BMJ Group 2011
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Accés en línia: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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