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Field safety notices released by manufacturers in cases of failure of products for infection testing: analysis of cases reported to the BfArM between 2005 and 2007

The European Directive 98/79/EC for in vitro diagnostic medical devices (IVD) regulates marketing and post marketing surveillance of IVD in the European Economic Area. Manufacturers have to inform the responsible Competent Authorities (CA) about incidents and field safety corrective actions (FSCA) r...

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Detalles Bibliográficos
Autores principales:	Siekmeier, R, Lisson, K, Wetzel, D
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	BioMed Central 2010
Materias:	Research
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4360290/ https://www.ncbi.nlm.nih.gov/pubmed/21147647 http://dx.doi.org/10.1186/2047-783X-15-S2-175

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