19. Design Change Control, Design Review, and Design History File

  1. Basem S. El-Haik and
  2. Khalid S. Mekki

Published Online: 15 APR 2008

DOI: 10.1002/9780470264003.ch19

Medical Device Design for Six Sigma: A Road Map for Safety and Effectiveness

Medical Device Design for Six Sigma: A Road Map for Safety and Effectiveness

How to Cite

El-Haik, B. S. and Mekki, K. S. (2008) Design Change Control, Design Review, and Design History File, in Medical Device Design for Six Sigma: A Road Map for Safety and Effectiveness, John Wiley & Sons, Inc., Hoboken, NJ, USA. doi: 10.1002/9780470264003.ch19

Publication History

  1. Published Online: 15 APR 2008
  2. Published Print: 11 APR 2008

ISBN Information

Print ISBN: 9780470168615

Online ISBN: 9780470264003

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Keywords:

  • design change control informal and formal processes;
  • change control process (CCP) and quality system regulation (QSR);
  • design history file (DHF)

Summary

This chapter contains sections titled:

  • Introduction

  • Design Change Control Process

  • Design Review

  • Design History File

  • Summary