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Software as a Medical Device: Regulatory Critical Issues.

, , , , and . ITCH, volume 183 of Studies in Health Technology and Informatics, page 337-342. IOS Press, (2013)

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A Framework for reporting on Human Factor/Usability studies of Health Information Technologies., , , , , and . CSHI, volume 194 of Studies in Health Technology and Informatics, page 54-60. IOS Press, (2013)Impact of the context of use analysis for the extension of an existing medical device: an analgesia monitor case study., , , , , and . CSHI, volume 194 of Studies in Health Technology and Informatics, page 139-144. IOS Press, (2013)Usability and Safety of Software Medical Devices: Need for Multidisciplinary Expertise to Apply the IEC 62366: 2007., , , and . MedInfo, volume 216 of Studies in Health Technology and Informatics, page 353-357. IOS Press, (2015)Software as a Medical Device: Regulatory Critical Issues., , , , and . ITCH, volume 183 of Studies in Health Technology and Informatics, page 337-342. IOS Press, (2013)Application of the Medical Device Directive to Software: Methodological Challenges., , , , , , and . MedInfo, volume 192 of Studies in Health Technology and Informatics, page 437-441. IOS Press, (2013)