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Good Manufacturing Practice / Quality Systems

• New Quality System (QS) Regulation
  • FDA Talk Paper Announcing the GMP Final Rule
  • The Good Manufacturing Practice (GMP - Quality System Regulation) Final Rule
    Text PDF ZIP

• Design Controls
  • Design Control Guidance for Medical Device Manufacturers
    Text PDF

• Human Factors
  • FDA Human Factor Program
  • Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management
  • Do It By Design: An Introduction to Human Factors in Medical Devices
    Text PDF
  • Human Factors Implications of the New GMP Rule

• Other Related Information
  • Medical Device Quality Systems Manual: A Small Entity Compliance Guide
  • QSIT Inspection Handbook
    Text PDF
  • GMP/QS Workshops with CDRH Participation