Medical device design for six sigma : a road map for safety and effectiveness / / Basem S. El-Haik, Khalid S. Mekki.

• Author: ProQuest (Firm); El-Haik, Basem.
• TeilnehmendeR: Mekki, Khalid S.; ProQuest (Firm)
• Year of Publication: 2008
• Language: English
• Physical Description: xxvii, 528 p. :; ill.

Table of Contents

• Medical device design quality
• Design for six sigma and medical device regulation
• Basic statistics
• The six sigma process
• Medical device design for six sigma
• Medical device DFSS deployment
• Medical device DFSS project road map
• Quality function deployment
• DFSS axiomatic design method
• DFSS innovation for medical devices
• DFSS risk management process
• Medical device design for X
• DFSS transfer function and scorecards
• Fundamentals of experimental design
• Robust parameter design for medical devices
• Medical device tolerance design
• Medical device DFSS verification and validation
• DFSS design transfer
• Design change control, design review, and design history file
• Medical device DFSS case study.