Design Controls for the Medical Device Industry, Third Edition

ISBN-13: 9780815365525 / Angielski / Twarda / 2019 / 248 str.

Marie B. Teixeira; Richard Bradley

Opis

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 design control program that not only satisfies the US FDA Quality Systems Regulation (QSR) and ISO 9001:2015 and 13485:2016 standards, but also meets today's Notified Body auditors' and FDA investigators' expectations. Areas addressed are design planning, input, output, review, verification, validation, change, transfer and history. The FDA Quality System Inspection Technique (QSIT) is also covered in-depth.

Spis treści

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.