Design Controls for the Medical Device Industry

Marie B. Teixeira, Marie Teixeira, Richard Bradley

• Éditeur: CRC Press
• Année: 2013
• ISBN:
  9781466503557
• Édition: 2
• Sujet: Médecine
• Sous-sujet: Biotechnologie en médecine

The second edition of a bestseller, Design Controls for the Medical Device Industry provides a comprehensive review of the latest design control requirements, as well as proven tools and techniques to ensure your company's design control program evolves in accordance with current industry practice. The text assists in the development of an effectiv

Table des matières

• Front Cover
• Contents
• Preface
• About the Author
• Chapter 1: Introduction
• Chapter 2: Device classification
• Chapter 3: Overview of design controls
• Chapter 4: Design and development planning
• Chapter 5: Design inputs—Part I
• Chapter 6: Design inputs—Part II
• Chapter 7: Design outputs
• Chapter 8: Design review
• Chapter 9: Design verification
• Chapter 10
• Chapter 11
• Chapter 12
• Chapter 13
• Chapter 14
• Chapter 15
• Chapter 16
• Appendix A—QARA Compliance Connection, Inc.: Design control procedure
• Appendix B—QARA Compliance Connection, Inc.: Product performance specification
• Appendix C—QARA Compliance Connection, Inc.: CE product claims sheet
• Appendix D—QARA Compliance Connection, Inc.: Design inputs and associated outputs matrix
• Appendix E—QARA Compliance Connection, Inc.: Project approval form
• Appendix F—Design review meeting record
• Appendix G—QARA Compliance Connection, Inc.: Risk management plan
• Appendix H—QARA Compliance Connection, Inc.: Clinical evaluation report form
• Appendix I—QARA Compliance Connection, Inc.: Design transfer checklist
• Appendix J—QARA Compliance Connection, Inc.: Design change form
• Appendix K—QARA Compliance Connection, Inc.: Approval for sale
• References
• Back Cover