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Guidance for Industry, Third Parties and Food and Drug Administration Staff – Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program (FDA 20123.19)
Guidance for Industry Process Validation: General Principles and Practices (2011.1)
ラベリングとは
UDI(個体識別、Unique Device Identification)
FDA QSR入門セミナー
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