Maturity assessment of software-driven medical technologies: a quantitative score derived from a quality standard for the research phase *
Jean-Loup Haberbusch,
Guillaume Dardenne,
Emmanuel Promayon
Abstract:Quantitatively assessing the level of readiness of medical technology improves its chance of successfully transfer from research to industry but remains a challenge. As many innovative medical devices are associated with or incorporate software, this article presents a methodology for evaluating the software maturity of a "Software-driven Medical Technology" (SdMT) during the research phase. A technological maturity model is developed by methodologically extracting relevant terms from the ISO/IEC 62304 standar… Show more
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