Design Controls for the Medical Device Industry, Third Edition
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Design Controls for the Medical Device Industry, Third Edition
Teixeira, Marie B.
Taylor & Francis Inc
08/2019
248
Dura
Inglês
9780815365525
15 a 20 dias
467
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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.
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
Intraocular Lenses;Device Classification;FDA 510k;Design and Development Planning;FDA's Quality System;Risk Management;Design Input Requirements;Quality System Inspection Technique;Chocolate Chip Cookie;Design History File;FDA's Guidance Document;Design Control Requirements;Biocompatibility Testing;FDA's Quality System Regulation;Making Chocolate Chip Cookies;Design Verification Activities;Medical Device;Pert Chart;Design Review Meeting;Medical Device Classification;Test Article;IRB;Institutional Review Boards;Design Verification;Design Transfer Process;Medical Device Classes;Design Transfer;Design Output;Design Validation
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.
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
Intraocular Lenses;Device Classification;FDA 510k;Design and Development Planning;FDA's Quality System;Risk Management;Design Input Requirements;Quality System Inspection Technique;Chocolate Chip Cookie;Design History File;FDA's Guidance Document;Design Control Requirements;Biocompatibility Testing;FDA's Quality System Regulation;Making Chocolate Chip Cookies;Design Verification Activities;Medical Device;Pert Chart;Design Review Meeting;Medical Device Classification;Test Article;IRB;Institutional Review Boards;Design Verification;Design Transfer Process;Medical Device Classes;Design Transfer;Design Output;Design Validation
