| Description |
1 online resource (xix, 424 pages) |
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text txt rdacontent |
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computer c rdamedia |
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online resource cr rdacarrier |
| Bibliography |
Includes bibliographical references and index. |
| Note |
Print version record. |
| Contents |
Machine 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 -- Risk Management and Validation of Medical Device Software -- About This Book -- Goals of This Book -- Intended Audience -- Are You Wasting Time? -- References -- ch. 2 Regulatory Background -- FDA: 1906 Through 1990 -- FDA Today (2009) -- How the FDA Assures Safety, Efficacy, and Security -- Quality System Regulations and Design Controls -- Understanding How Regulation Relates to Getting the Job Done -- Medical Devices Sold Outside the United States -- References -- ch. 3 FDA Software Validation Regulations and Why You Should Validate Software Anyway -- ^ |
| Summary |
Here'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. Publisher abstract. |
| Subject |
Medical instruments and apparatus -- Software.
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Software engineering.
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Computer software -- Quality control.
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Software Validation |
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Device Approval -- standards |
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Software -- standards |
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Génie logiciel.
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Logiciels -- Qualité -- Contrôle.
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Logiciels -- Validation.
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Médecine -- Appareils et instruments -- Logiciels.
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MEDICAL -- Instruments & Supplies.
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Computer software -- Quality control
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Medical instruments and apparatus
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Software engineering
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| Genre/Form |
Electronic books.
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Software
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| Other Form: |
Print version: Medical device software verification, validation and compliance. Boston : Artech House, 2010 9781596934221 (OCoLC)654313446 |
| ISBN |
9781596934238 (electronic bk.) |
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1596934239 (electronic bk.) |
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9781523117390 (electronic bk.) |
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1523117397 (electronic bk.) |
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9781596934221 |
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1596934220 |
| Standard No. |
AU@ 000051445434 |
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DEBBG BV043068860 |
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DEBSZ 421659335 |
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NZ1 13934970 |
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