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UDI(個体識別、Unique Device Identification)
FDA対応工程設計の要点
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)
UDI Rule and Guidances, Training, Resources, and Dockets
Guidance for Industry Process Validation: General Principles and Practices (2011.1)
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