{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,2,22]],"date-time":"2025-02-22T05:36:28Z","timestamp":1740202588494,"version":"3.37.3"},"reference-count":0,"publisher":"IOS Press","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2013]]},"abstract":"<jats:p>The European Union (EU) adopted the revised Medical Device Directive (MDD) in 2010. A major change is that software for certain purposes is now considered a medical device (MD) and thus is subject to the same regulation as MDs. That means the integration of a usability engineering process with its documentation in a usability file is now mandatory. This paper presents a case study, performed in particular conditions, to (i) illustrate the adopted user-centered approach to be compliant with the ergonomic-essential requirement and (ii) discuss the methodological challenges associated even under such favorable conditions. The results raise the question about whether software regulation is feasible. We conclude that there is a need to think about recommendations for how regulation could be implemented with support for manufacturers, with minimal impact on innovation, and with rigorous but not too rigid evaluation procedures.<\/jats:p>","DOI":"10.3233\/978-1-61499-289-9-437","type":"book-chapter","created":{"date-parts":[[2025,2,21]],"date-time":"2025-02-21T17:29:25Z","timestamp":1740158965000},"source":"Crossref","is-referenced-by-count":0,"title":["Application of the Medical Device Directive to Software: Methodological Challenges"],"prefix":"10.3233","author":[{"family":"Pelayo Sylvia","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"family":"Bras Da Costa Sabrina","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"family":"Leroy Nicolas","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"family":"Loiseau S&eacute;verine","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"family":"MacKeon Damien","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"family":"Trancard Delphine","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"family":"Beuscart-Z&eacute;phir Marie-Catherine","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"7437","container-title":["Studies in Health Technology and Informatics","MEDINFO 2013"],"original-title":[],"deposited":{"date-parts":[[2025,2,21]],"date-time":"2025-02-21T17:45:16Z","timestamp":1740159916000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.medra.org\/servlet\/aliasResolver?alias=iospressISSNISBN&issn=0926-9630&volume=192&spage=437"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2013]]},"references-count":0,"URL":"https:\/\/doi.org\/10.3233\/978-1-61499-289-9-437","relation":{},"ISSN":["0926-9630"],"issn-type":[{"value":"0926-9630","type":"print"}],"subject":[],"published":{"date-parts":[[2013]]}}}