2. Design for Six Sigma and Medical Device Regulation

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

Published Online: 15 APR 2008

DOI: 10.1002/9780470264003.ch2

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 for Six Sigma and Medical Device Regulation, 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.ch2

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:

  • six sigma (DFSS) design and medical device regulation;
  • quality management systems regulation (QMSR);
  • product development life cycle

Summary

This chapter contains sections titled:

  • Introduction

  • Global Perspective on Medical Device Regulations

  • Medical Device Classification

  • Medical Device Safety

  • Medical Device Quality Management Systems Requirements

  • Medical Device Regulation Throughout the Product Development Life Cycle

  • Summary