First experiences with the implementation of the European standard EN 62304 on medical device software for the quality assurance of a radiotherapy unit

BACKGROUND: According to the latest amendment of the Medical Device Directive standalone software qualifies as a medical device when intended by the manufacturer to be used for medical purposes. In this context, the EN 62304 standard is applicable which defines the life-cycle requirements for the de...

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Detalles Bibliográficos
Autores principales: Höss, Angelika, Lampe, Christian, Panse, Ralf, Ackermann, Benjamin, Naumann, Jakob, Jäkel, Oliver
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2014
Materias:
Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3994433/
https://www.ncbi.nlm.nih.gov/pubmed/24655818
http://dx.doi.org/10.1186/1748-717X-9-79

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