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 E...

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Bibliographic Details
Main Authors: Heneghan, C, Thompson, M, Billingsley, M, Cohen, D
Format: Journal article
Language:English
Published: BMJ Publishing Group 2011