LEADER 03494nam 2200577Ia 450 001 9910818176403321 005 20200520144314.0 010 $a1-5231-1739-7 010 $a1-59693-423-9 035 $a(CKB)2670000000059197 035 $a(EBL)624054 035 $a(OCoLC)694729137 035 $a(SSID)ssj0000471248 035 $a(PQKBManifestationID)11299288 035 $a(PQKBTitleCode)TC0000471248 035 $a(PQKBWorkID)10427383 035 $a(PQKB)11268465 035 $a(Au-PeEL)EBL624054 035 $a(CaPaEBR)ebr10436227 035 $a(CaBNVSL)mat09100334 035 $a(IEEE)9100334 035 $a(MiAaPQ)EBC624054 035 $a(EXLCZ)992670000000059197 100 $a20101007d2010 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 10$aMedical device software verification, validation and compliance /$fDavid A. Vogel 205 $a1st ed. 210 $aNorwood, MA $cArtech House$d2010 215 $a1 online resource (444 p.) 300 $aIncludes index. 311 $a1-59693-422-0 320 $aIncludes bibliographical references and index. 327 $aMachine generated contents note: pt. I Background -- ch. 1 Evolution of Medical Device Software Validation and the Need for This Book -- Evolution of Validation in the Medical Device Industry -- Building a Language to Discuss Validation -- Terminology is the Foundation -- Correct Versus Consistent Terminology -- Terminology Need Not Be Entertaining -- 330 3 $aHere's the first book written specifically to help medical device and software engineers, QA and compliance professionals, and corporate business managers better understand and implement critical verification and validation processes for medical device software. Offering you a much broader, higher-level picture than other books in this field, this book helps you think critically about software validation -- to build confidence in your software's safety and effectiveness. The book presents validation activities for each phase of the development lifecycle and shows: why these activities are important and add value; how to undertake them; and what outputs need to be created to document the validation process. From software embedded within medical devices, to software that performs as a medical device itself, this comprehensive book explains how properly handled validation throughout the development lifecycle can help bring medical devices to completion sooner, at higher quality, and in compliance with regulations. Additionally, an entire part of the book is devoted to the validation of software that automates any part of a manufacturer's quality system and is regulated by 21 CFR 820.70(i). DVD Included! Contains a collection of FDA regulations and guidance documents related to software in the medical device industry, valuable sample forms and templates, and supplemental figures that support key topics covered in the book.$cPublisher abstract. 606 $aMedical instruments and apparatus$xTesting 606 $aBiomedical engineering 615 0$aMedical instruments and apparatus$xTesting. 615 0$aBiomedical engineering. 676 $a610.285 700 $aVogel$b David A$01698416 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910818176403321 996 $aMedical device software verification, validation and compliance$94079846 997 $aUNINA