Imdrf Samd
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Final Document: Software as a Medical Device (SaMD ...
www.imdrf.orgThe IMDRF has acknowledged that software is an increasingly critical area of healthcare product development and has developed a series of documents concerning the definition, the categorization, and the application of quality systems principles of SaMD. In 2013, IMDRF’s SaMD Working Group released SaMD N10 [1] Software as a Medical Device
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
Update on Medical Device and IVD Regulation in Japan - …
www.pmda.go.jpperformance of SaMD using AI ... UDI based on GHTF/IMDRF 2. Conduct educational sessions for industry to sufficiently train the new regulation / requirements. • e.g. Seminar, Q&A, Consultation 3. Coordinated approach for the introduction of the new regulation / requirements.
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