Design Controls for the Medical Device Industry, Third Edition (Hardcover, 3)

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, FDA inspection technique, references, Appendix A - design controls PROCEDURE, Appendix B ? DESIGN INPUT DOCUMENT, Appendix C - Product Claims Sheet, Appendix D- DESIGN INPUT/OUTPUT TRACEABILITY MATRIX, Appendix e ? project approval form, Appendix f ? DESIGN PHASE REVIEW MEETING record, Appendix g ? Risk management plan template, Appendix H ? clinical evaluation report, Appendix I ? design transfer checklist, Appendix j ? design change form, Appendix j ? design change form, Appendix k ? approval for sale, Appendix L ? ENGINEERING CHANGE ORDER, Appendix L ? ENGINEERING CHANGE ORDER