1.

Record Nr.

UNINA9910812684003321

Autore

El-Haik Basem

Titolo

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

Pubbl/distr/stampa

Hoboken, N.J., : Wiley-Interscience, c2008

ISBN

9786612365140

9780470264003 (ebook)

9781118210413

1118210417

9781282365148

1282365142

9780470264003

0470264004

9780470263914

0470263911

Edizione

[2nd ed.]

Descrizione fisica

1 online resource (580 pages)

Altri autori (Persone)

MekkiKhalid S

Disciplina

610.284

Soggetti

Medical instruments and apparatus - Quality control

Medical instruments and apparatus - Safety measures

Six sigma (Quality control standard)

Lingua di pubblicazione

Inglese

Formato

Materiale a stampa

Livello bibliografico

Monografia

Note generali

"A John Wiley & Sons, Inc. publication."

Description based upon print version of record.

Nota di bibliografia

Includes bibliographical references (p. 510-521) and index.

Nota di contenuto

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.

Sommario/riassunto

The first comprehensive guide to the integration of Design for Six Sigma principles in the medical devices development cycle Medical Device Design for Six Sigma: A Road Map for Safety and Effectiveness presents the complete body of knowledge for Design for Six Sigma (DFSS), as outlined by American Society for Quality, and details how to integrate appropriate design methodologies up front in the design process. DFSS helps companies shorten lead times, cut development and manufacturing costs, lower total life-cycle cost, and improve the quality of the medical devices. Comprehensi