Marie B. Teixeira
August 30, 2019 Forthcoming
Reference - 208 Pages - 16 B/W Illustrations
ISBN 9780815365525 - CAT# K336422
For Instructors Request Inspection Copy
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 13485:2016 standards, but also meets today's Notified Body Auditors' and FDA Investigators' expectations.
The book includes a review of the design control elements such as design planning, input, output, review, verification, validation, change, transfer, and history, as well as risk management inclusive of human factors and usability, biocompatibility, the FDA Quality System Inspection Technique (QSIT) for design controls, and medical device regulations and classes in the US, Canada, and Europe. Practical advice, methods and appendixes are provided to assist with implementation of a compliant design control program and extensive references are provided for further study.
This third edition:
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, FDA inspection technique, references, Appendix A - design controls PROCEDURE, Appendix B – DESIGN INPUT DOCUMENT, Appendix C - Product Claims Sheet, Appendix D- DESIGN INPUT/OUTPUT TRACEABILITY MATRIX, Appendix e – project approval form, Appendix f – DESIGN PHASE REVIEW MEETING record, Appendix g – Risk management plan template, Appendix H – clinical evaluation report, Appendix I – design transfer checklist, Appendix j – design change form, Appendix j – design change form, Appendix k – approval for sale, Appendix L – ENGINEERING CHANGE ORDER, Appendix L – ENGINEERING CHANGE ORDER