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The dilemma of reporting device-related adverse events



The dilemma of reporting device-related adverse events



Medical Device Technology 14(1): 26-31



One of the most difficult decisions that medical device companies may face is whether or not to report an adverse event to regulatory authorities. This article discusses a series of UK vigilance guidance documents for device implants designed to assist manufacturers in making these decisions and the wider value to industry that these documents may have.

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Accession: 050603856

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PMID: 12974122


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