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IMDRFInternational Medical Device Regulators Forum/SaMD WG/N12FINAL:2014 Title "Software as a Medical Device": Possible Framework for Risk Categorization and Corresponding Considerations Authoring Group IMDRF Software as a Medical Device (SaMD) Working Group Date 18 September 2014 7.2 SaMD Categories State of Healthcare situation or condition Critical Serious Non serious SaMD Categories IMDRF Significance of information provided by SaMD to healthcare decision Treat or diagnose Drive clinical management Inform clinical management IV III II III II I II I I http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-140918-samd-framework-risk-categorization-141013.pdf
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13 公 益 財 団 法 人 医 療 機 器 センター 第 10 回 医 療 機 器 産 業 研 究 会 配 布 資 料
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QMSISO13485+ GQP 2 ISO13485 3 QMS 25
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