{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,8]],"date-time":"2025-11-08T23:05:59Z","timestamp":1762643159704},"reference-count":0,"publisher":"IOS Press","license":[{"start":{"date-parts":[[2022,8,31]],"date-time":"2022-08-31T00:00:00Z","timestamp":1661904000000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,8,31]]},"abstract":"<jats:p>Certification of Medical Device Software (MDS) according to the EU Medical Device Regulation 2017\/745 requires demonstrating safety and effectiveness. Thus, the syllabus of a course on MDS development must provide tools for addressing these issues. To assure safety, risk analysis has to be performed using a four-step procedure. Effectiveness could be demonstrated by literature systematic review combined with meta-analysis, to compare the MDS performances with those of similar tools.<\/jats:p>","DOI":"10.3233\/shti220928","type":"book-chapter","created":{"date-parts":[[2022,9,5]],"date-time":"2022-09-05T07:24:10Z","timestamp":1662362650000},"source":"Crossref","is-referenced-by-count":0,"title":["Key Aspects to Teach Medical Device Software Certification"],"prefix":"10.3233","author":[{"given":"Noemi","family":"Giordano","sequence":"first","affiliation":[{"name":"Department of Electronics and Telecommunications, Politecnico di Torino, Torino, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Samanta","family":"Rosati","sequence":"additional","affiliation":[{"name":"Department of Electronics and Telecommunications, Politecnico di Torino, Torino, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marco","family":"Knaflitz","sequence":"additional","affiliation":[{"name":"Department of Electronics and Telecommunications, Politecnico di Torino, Torino, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gabriella","family":"Balestra","sequence":"additional","affiliation":[{"name":"Department of Electronics and Telecommunications, Politecnico di Torino, Torino, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"7437","container-title":["Studies in Health Technology and Informatics","Digital Professionalism in Health and Care: Developing the Workforce, Building the Future"],"original-title":[],"link":[{"URL":"https:\/\/ebooks.iospress.nl\/pdf\/doi\/10.3233\/SHTI220928","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,9,5]],"date-time":"2022-09-05T07:24:11Z","timestamp":1662362651000},"score":1,"resource":{"primary":{"URL":"https:\/\/ebooks.iospress.nl\/doi\/10.3233\/SHTI220928"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,8,31]]},"references-count":0,"URL":"https:\/\/doi.org\/10.3233\/shti220928","relation":{},"ISSN":["0926-9630","1879-8365"],"issn-type":[{"value":"0926-9630","type":"print"},{"value":"1879-8365","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,8,31]]}}}