Design Controls for the Medical Device Industry, Third Edition

Introduction. Device classification. Overview of design controls. Design and development planning. Design inputs: Part I. Design inputs: Part II. Design outputs. Design review. Design verification. Risk management. Design validation. Biocompatibility. Design transfer. Design change. Design history file. The FDA inspection technique. Appendix A: Design controls procedure. Appendix B: Design input document. Appendix C: Product claims sheet. Appendix D: Input/Output design traceability matrix. Appendix E: Project approval form. Appendix F: Design phase review meeting record. Appendix G: Risk analysis. Appendix H: Clinical evaluation report. Appendix I: Design transfer checklist. Appendix J: Design change form. Appendix K: Approval for sale form. Appendix L: Engineering change order form.

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• Tecnologia farmacêutica
• Ciência dos materiais
• Biotecnologia
• Engenharia biomédica

medical device compliance;FDA QSR standards;ISO 13485 implementation;risk management processes;human factors engineering;regulatory audit preparation;design control regulatory documentation