- 参考
21 CFR Part820 Quality System Regulation, FDA 1997
Design Control Guidance For Medical Device Manufacturers, FDA 11 March,1997
FDA査察対応設計管理手順書サンプル
イーコンプライアンスでは、FDAが要求する設計管理に対応した、規程、手順書、様式のサンプルを販売しています。
ぜひご購入をご検討下さい。
21 CFR Part820 Quality System Regulation, FDA 1997
Design Control Guidance For Medical Device Manufacturers, FDA 11 March,1997
イーコンプライアンスでは、FDAが要求する設計管理に対応した、規程、手順書、様式のサンプルを販売しています。
ぜひご購入をご検討下さい。
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Pierce, Greg (September 22, 2008).
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Fischer, David Hackett (2006).
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