17. Medical Device DFSS Verification and Validation

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

Published Online: 15 APR 2008

DOI: 10.1002/9780470264003.ch17

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) Medical Device DFSS Verification and Validation, 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.ch17

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:

  • medical device DFSS verification and validation;
  • design verification process and design change magnitude;
  • device production process validation

Summary

This chapter contains sections titled:

  • Introduction

  • Design Verification Process

  • Production Process Validation

  • Software Validation

  • Design Validation

  • Summary