Archivio Istituzionale della RicercaCertification 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.
Key Aspects to Teach Medical Device Software Certification / Giordano, Noemi; Rosati, Samanta; Knaflitz, Marco; Balestra, Gabriella. - ELETTRONICO. - (2022), pp. 159-160. (Intervento presentato al convegno EFMI Special Topic Conference 2022 tenutosi a Cardiff, Wales nel 7-8 September 2022) [10.3233/SHTI220928].
Key Aspects to Teach Medical Device Software Certification
Giordano, Noemi;Rosati, Samanta;Knaflitz, Marco;Balestra, Gabriella
2022
Abstract
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.
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https://hdl.handle.net/11583/2971085