Contrasting clinical evidence for market authorisation of cardio-vascular devices in Europe and the USA: a systematic analysis of 10 devices based on Austrian pre-reimbursement assessments

BACKGROUND: European medical device regulation is under scrutiny and will be re-regulated with stricter rules concerning requirements for clinical evidence for high-risk medical devices. It is the aim of this study to analyse the differences between Europe and USA in dealing with risks and benefits...

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Detalles Bibliográficos
Autores principales: Wild, Claudia, Erdös, Judit, Zechmeister, Ingrid
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2014
Materias:
Research Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4232631/
https://www.ncbi.nlm.nih.gov/pubmed/25366498
http://dx.doi.org/10.1186/1471-2261-14-154

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4232631/
https://www.ncbi.nlm.nih.gov/pubmed/25366498
http://dx.doi.org/10.1186/1471-2261-14-154

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