Design Controls for the Medical Device Industry

Preface Author Biography 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 Quality System Inspection Technique References Appendix A - Design Controls Procedure Appendix B - Product Performance Specification Appendix C - Product Claims Sheet Appendix D - Design Input/Output Matrix Appendix E - Project Approval Form Appendix F - Design Review Meeting Record Template Appendix G - Risk Management Plan Template Appendix H - Clinical Evaluation Report Template Appendix I - Design Transfer Checklist Appendix J - Design Change Form Template Appendix K - Approval for Sale Template Index

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• Biotecnologia
• Engenharia biomédica
• Ciência dos materiais