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. (QA/RA Compliance Connection, Inc., Odessa, Florida, USA)
Taylor & Francis Inc
08/2019
248
Dura
Inglês
9780815365525
Pré-lançamento - envio 15 a 20 dias após a sua edição
"A CRC title, part of the Taylor & Francis imprint, a member of the Taylor & Francis Group, the academic division of T&F Informa plc."
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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"A CRC title, part of the Taylor & Francis imprint, a member of the Taylor & Francis Group, the academic division of T&F Informa plc."
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.
