文書管理で重要なこと
Computerized System(コンピュータ化システム)とは
規制要件とは
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 Basics
UDI Rule and Guidances, Training, Resources, and Dockets
UDI(個体識別、Unique Device Identification)
機器履歴簿(DHF)
FDA対応設計インプットの要点