Usability and Safety of Software Medical Devices: Need for Multidisciplinary Expertise to Apply the IEC 62366: 2007

• Published in: Studies in health technology and informatics Vol. 216; p. 353
• Main Authors: Bras Da Costa, Sabrina, Beuscart-Zéphir, M C, Bastien, J-M Christian, Pelayo, Sylvia
• Format: Journal Article
• Language: English
• Published: Netherlands 2015
• Subjects: Equipment and Supplies - standards; Equipment Failure Analysis - standards; Equipment Safety - standards; France; Guideline Adherence - organization & administration; Guideline Adherence - standards; Internationality; Needs Assessment - standards; Practice Guidelines as Topic; Professional Competence - standards; Software - standards; Utilization Review - standards

Software medical devices must now comply with the "ergonomics" essential requirement of the Medical Device Directive. However, the usability standard aiming to guide the manufacturers is very difficult to understand and apply. Relying on a triangulation of methods, this study aims to highl...