Design controls for the medical device industry /
This third edition provides a substantial comprehensive review of the latest design control requirements, as well as proven tools and techniques to ensure a company's design control program evolves in accordance with current industry practice. It assists in the development of an effective desig...
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| Format: | Book |
| Language: | English |
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Boca Raton, FL :
CRC Press,
2020
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| Edition: | Third edition |
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Table of Contents:
- 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
- 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