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Journal Articles Studies in Health Technology and Informatics Year : 2013

Software as a medical device: regulatory critical issues.

Abstract

The revised Medical Device Directive has been adopted by the EU in 2010. A major change is that software for certain purposes is now considered a medical device. This entails that a new view needs to be developed on the design, development, evaluation and post-market surveillance of medical software that meets the definition of a medical device. This paper identifies some issues at stake and discusses them.
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Dates and versions

hal-01376784 , version 1 (05-10-2016)

Identifiers

  • HAL Id : hal-01376784 , version 1
  • PUBMED : 23388310

Cite

Sylvia Pelayo, Sabrina Bras da Costa, Nicolas Leroy, Séverine Loiseau, Marie-Catherine Beuscart-Zephir. Software as a medical device: regulatory critical issues.. Studies in Health Technology and Informatics, 2013, 183, pp.337-42. ⟨hal-01376784⟩
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