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Record Nr. |
UNINA9910812684003321 |
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Autore |
El-Haik Basem |
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Titolo |
Medical device design for six sigma : a road map for safety and effectiveness / / Basem S. El-Haik, Khalid S. Mekki |
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Pubbl/distr/stampa |
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Hoboken, N.J., : Wiley-Interscience, c2008 |
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ISBN |
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9786612365140 |
9780470264003 (ebook) |
9781118210413 |
1118210417 |
9781282365148 |
1282365142 |
9780470264003 |
0470264004 |
9780470263914 |
0470263911 |
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Edizione |
[2nd ed.] |
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Descrizione fisica |
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1 online resource (580 pages) |
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Altri autori (Persone) |
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Disciplina |
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Soggetti |
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Medical instruments and apparatus - Quality control |
Medical instruments and apparatus - Safety measures |
Six sigma (Quality control standard) |
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Lingua di pubblicazione |
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Formato |
Materiale a stampa |
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Livello bibliografico |
Monografia |
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Note generali |
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"A John Wiley & Sons, Inc. publication." |
Description based upon print version of record. |
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Nota di bibliografia |
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Includes bibliographical references (p. 510-521) and index. |
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Nota di contenuto |
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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, |
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design review, and design history file -- Medical device DFSS case study. |
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Sommario/riassunto |
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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 |
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