FDA対応設計審査(Design Review)の要点

  • 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。

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