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PowerPoint 簡報 - 北醫知識管理與學習網 2013年9月12日 ... 醫療器材簡介. • 簡介醫工產品化主要的認證內容. • ISO13485 認證範例說明,. • ICE60601-2 電器安規範例說明. • EMT 及ＦＤＡ 510k 認證範例說明.
醫療器材軟體確效法規要求介紹 - 長庚大學電機工程學系 品質管理系統(ISO 13485)文件架構圖. 風險管理(ISO 14971)介紹. 醫療器材的安全 與品質直接攸關人身安全，因此全球各國不單只是對醫療器材產品進行全面的控管 ...
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