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

Incluye bibliografía.

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.