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Software as a Medical Device (SaMD): Key definitions - IMDRF
www.imdrf.orgIMDRF/SaMD WG/N10FINAL:2013 _____ 2.0 Scope . This document IMDRF SaMD WG N10/Software as a Medical Device: Key Definitions focuses
令和2年5月13日 厚生労働省医薬・生活衛生局医療機器審査管 …
www.mhlw.go.jpしい。その他の関連文書である「IMDRF/SaMD WG/N12 FINAL: 2014」の9.3 項では、 安全を考慮する際の情報セキュリティの重要性について記載されており、医療機器ソフ トウェア（Software as Medical Device：SaMD）の情報セキュリティに影響する幾つかの
IMDRF/SaMD WG/N23 FINAL: 2015 - Software as a Medical ...
www.imdrf.orgThe IMDRF/SaMD WG/N12 document also highlights the use of quality management as a general consideration towards the safety, effectiveness, and performance of SaMD and as key to ensuring the predictability and quality of SaMD. Quality Management System (QMS) principles, for many industrial sectors, can be found in the