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Software as a Medical Device: Regulatory Critical Issues
Sylvia Pelayo, Sabrina Bras Da Costa, Nicolas Leroy, Séverine Loiseau, Marie-Catherine Beuscart-Zephir
337 - 342
10.3233/978-1-61499-203-5-337
Studies in Health Technology and Informatics
Volume 183: Enabling Health and Healthcare through ICT
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.

$35.00 / €27.50 / £22.00
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