Medical device software verification, validation and compliance /:
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, hig...
Gespeichert in:
| 1. Verfasser: | |
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| Format: | Elektronisch E-Book |
| Sprache: | English |
| Veröffentlicht: |
Boston :
Artech House,
©2011.
|
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Zusammenfassung: | 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. |
| Beschreibung: | 1 online resource (xix, 424 pages) |
| Bibliographie: | Includes bibliographical references and index. |
| ISBN: | 9781596934238 1596934239 9781523117390 1523117397 |
Internformat
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| 245 | 1 | 0 | |a Medical device software verification, validation and compliance / |c David A. Vogel. |
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| 300 | |a 1 online resource (xix, 424 pages) | ||
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| 504 | |a Includes bibliographical references and index. | ||
| 588 | 0 | |a Print version record. | |
| 505 | 0 | 0 | |g Machine generated contents note: |g pt. I |t Background -- |g ch. 1 |t Evolution of Medical Device Software Validation and the Need for This Book -- |t Evolution of Validation in the Medical Device Industry -- |t Building a Language to Discuss Validation -- |t Terminology is the Foundation -- |t Correct Versus Consistent Terminology -- |t Terminology Need Not Be Entertaining -- |t Risk Management and Validation of Medical Device Software -- |t About This Book -- |t Goals of This Book -- |t Intended Audience -- |t Are You Wasting Time? -- |t References -- |g ch. 2 |t Regulatory Background -- |t FDA: 1906 Through 1990 -- |t FDA Today (2009) -- |t How the FDA Assures Safety, Efficacy, and Security -- |t Quality System Regulations and Design Controls -- |t Understanding How Regulation Relates to Getting the Job Done -- |t Medical Devices Sold Outside the United States -- |t References -- |g ch. 3 |t FDA Software Validation Regulations and Why You Should Validate Software Anyway -- ^ |
| 520 | 3 | |a 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. |c Publisher abstract. | |
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| 650 | 1 | 2 | |a Software Validation |
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| 650 | 2 | 2 | |a Software |x standards |
| 650 | 6 | |a Génie logiciel. | |
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| 650 | 6 | |a Logiciels |x Validation. | |
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Datensatz im Suchindex
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| adam_text | |
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| author | Vogel, David A. |
| author_facet | Vogel, David A. |
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| contents | Background -- 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 -- 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 -- FDA Software Validation Regulations and Why You Should Validate Software Anyway -- ^ |
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| dewey-raw | 610.28/4 |
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| dewey-sort | 3610.28 14 |
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| discipline | Medizin |
| format | Electronic eBook |
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| genre | Electronic books. Software fast |
| genre_facet | Electronic books. Software |
| id | ZDB-4-EBA-ocn694732909 |
| illustrated | Not Illustrated |
| indexdate | 2024-11-27T13:17:38Z |
| institution | BVB |
| isbn | 9781596934238 1596934239 9781523117390 1523117397 |
| language | English |
| oclc_num | 694732909 |
| open_access_boolean | |
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| owner_facet | MAIN DE-863 DE-BY-FWS |
| physical | 1 online resource (xix, 424 pages) |
| psigel | ZDB-4-EBA |
| publishDate | 2011 |
| publishDateSearch | 2011 |
| publishDateSort | 2011 |
| publisher | Artech House, |
| record_format | marc |
| spelling | Vogel, David A., author. Medical device software verification, validation and compliance / David A. Vogel. Boston : Artech House, ©2011. 1 online resource (xix, 424 pages) text txt rdacontent computer c rdamedia online resource cr rdacarrier Includes bibliographical references and index. Print version record. 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 -- ^ 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. Medical instruments and apparatus Software. Software engineering. http://id.loc.gov/authorities/subjects/sh87007398 Computer software Quality control. http://id.loc.gov/authorities/subjects/sh97003403 Software Validation Device Approval standards Software standards Génie logiciel. Logiciels Qualité Contrôle. Logiciels Validation. Médecine Appareils et instruments Logiciels. MEDICAL Instruments & Supplies. bisacsh Computer software Quality control fast Medical instruments and apparatus fast Software engineering fast Electronic books. Software fast has work: Medical device software verification, validation and compliance (Text) https://id.oclc.org/worldcat/entity/E39PCFVxK77QVy3Md4MDj9t8yd https://id.oclc.org/worldcat/ontology/hasWork Print version: Medical device software verification, validation and compliance. Boston : Artech House, 2010 9781596934221 (OCoLC)654313446 FWS01 ZDB-4-EBA FWS_PDA_EBA https://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&AN=347638 Volltext |
| spellingShingle | Vogel, David A. Medical device software verification, validation and compliance / Background -- 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 -- 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 -- FDA Software Validation Regulations and Why You Should Validate Software Anyway -- ^ Medical instruments and apparatus Software. Software engineering. http://id.loc.gov/authorities/subjects/sh87007398 Computer software Quality control. http://id.loc.gov/authorities/subjects/sh97003403 Software Validation Device Approval standards Software standards Génie logiciel. Logiciels Qualité Contrôle. Logiciels Validation. Médecine Appareils et instruments Logiciels. MEDICAL Instruments & Supplies. bisacsh Computer software Quality control fast Medical instruments and apparatus fast Software engineering fast |
| subject_GND | http://id.loc.gov/authorities/subjects/sh87007398 http://id.loc.gov/authorities/subjects/sh97003403 |
| title | Medical device software verification, validation and compliance / |
| title_alt | Background -- 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 -- 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 -- FDA Software Validation Regulations and Why You Should Validate Software Anyway -- ^ |
| title_auth | Medical device software verification, validation and compliance / |
| title_exact_search | Medical device software verification, validation and compliance / |
| title_full | Medical device software verification, validation and compliance / David A. Vogel. |
| title_fullStr | Medical device software verification, validation and compliance / David A. Vogel. |
| title_full_unstemmed | Medical device software verification, validation and compliance / David A. Vogel. |
| title_short | Medical device software verification, validation and compliance / |
| title_sort | medical device software verification validation and compliance |
| topic | Medical instruments and apparatus Software. Software engineering. http://id.loc.gov/authorities/subjects/sh87007398 Computer software Quality control. http://id.loc.gov/authorities/subjects/sh97003403 Software Validation Device Approval standards Software standards Génie logiciel. Logiciels Qualité Contrôle. Logiciels Validation. Médecine Appareils et instruments Logiciels. MEDICAL Instruments & Supplies. bisacsh Computer software Quality control fast Medical instruments and apparatus fast Software engineering fast |
| topic_facet | Medical instruments and apparatus Software. Software engineering. Computer software Quality control. Software Validation Device Approval standards Software standards Génie logiciel. Logiciels Qualité Contrôle. Logiciels Validation. Médecine Appareils et instruments Logiciels. MEDICAL Instruments & Supplies. Computer software Quality control Medical instruments and apparatus Software engineering Electronic books. Software |
| url | https://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&AN=347638 |
| work_keys_str_mv | AT vogeldavida medicaldevicesoftwareverificationvalidationandcompliance |