LEADER 03508nam 2200673 a 450 001 9910812684003321 005 20200520144314.0 010 $a1-118-21041-7 010 $a1-282-36514-2 010 $a9786612365140 010 $a9780470264003 (ebook) 010 $a0-470-26400-4 010 $a0-470-26391-1 035 $a(CKB)1000000000687314 035 $a(EBL)468995 035 $a(OCoLC)609847698 035 $a(SSID)ssj0000302893 035 $a(PQKBManifestationID)11213097 035 $a(PQKBTitleCode)TC0000302893 035 $a(PQKBWorkID)10275065 035 $a(PQKB)10375370 035 $a(MiAaPQ)EBC468995 035 $a(MiAaPQ)EBC4445050 035 $a(Au-PeEL)EBL468995 035 $a(CaPaEBR)ebr10296501 035 $a(CaONFJC)MIL236514 035 $a(EXLCZ)991000000000687314 100 $a20070915d2008 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 10$aMedical device design for six sigma $ea road map for safety and effectiveness /$fBasem S. El-Haik, Khalid S. Mekki 205 $a2nd ed. 210 $aHoboken, N.J. $cWiley-Interscience$dc2008 215 $a1 online resource (580 pages) 300 $a"A John Wiley & Sons, Inc. publication." 300 $aDescription based upon print version of record. 311 $a0-470-16861-7 320 $aIncludes bibliographical references (p. 510-521) and index. 327 $aMedical 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. 330 $aThe 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 606 $aMedical instruments and apparatus$xQuality control 606 $aMedical instruments and apparatus$xSafety measures 606 $aSix sigma (Quality control standard) 615 0$aMedical instruments and apparatus$xQuality control. 615 0$aMedical instruments and apparatus$xSafety measures. 615 0$aSix sigma (Quality control standard) 676 $a610.284 700 $aEl-Haik$b Basem$0908411 701 $aMekki$b Khalid S$01753974 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910812684003321 996 $aMedical device design for six sigma$94190060 997 $aUNINA