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Premarket evaluation of medical devices: a cross-sectional analysis of clinical studies submitted to a German ethics committee

OBJECTIVE: To assess the methodological quality of pre-market clinical studies performed on medical devices (MDs), including in-vitro diagnostic (IVD) MDs, in Europe. DESIGN: Observational cross-sectional study. SETTING: A large German ethics committee. MATERIALS: From the consecutive sample of stud...

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Detalles Bibliográficos
Autores principales:	Sauerland, Stefan, Fujita-Rohwerder, Naomi, Zens, Yvonne, Molnar, Sandra
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	BMJ Publishing Group 2019
Materias:	Research Methods
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6398724/ https://www.ncbi.nlm.nih.gov/pubmed/30798319 http://dx.doi.org/10.1136/bmjopen-2018-027041

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