Coverart for item
The Resource Medical device software verification, validation and compliance, David A. Vogel

Medical device software verification, validation and compliance, David A. Vogel

Label
Medical device software verification, validation and compliance
Title
Medical device software verification, validation and compliance
Statement of responsibility
David A. Vogel
Creator
Author
Subject
Genre
Language
eng
Member of
Cataloging source
N$T
http://library.link/vocab/creatorName
Vogel, David A
Dewey number
610.28/4
Index
index present
LC call number
R856.6
LC item number
.V64 2011eb
Literary form
non fiction
Nature of contents
  • dictionaries
  • bibliography
http://library.link/vocab/subjectName
  • Medical instruments and apparatus
  • Software engineering
  • Computer software
Label
Medical device software verification, validation and compliance, David A. Vogel
Instantiates
Publication
Antecedent source
unknown
Bibliography note
Includes bibliographical references and index
Carrier category
online resource
Carrier category code
  • cr
Carrier MARC source
rdacarrier
Color
multicolored
Content category
text
Content type code
  • txt
Content type MARC source
rdacontent
Contents
  • 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
  • Machine generated contents note:
  • 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 -- ̂
  • 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
Dimensions
unknown
Extent
1 online resource (xix, 424 pages)
File format
unknown
Form of item
online
Isbn
9781596934221
Level of compression
unknown
Media category
computer
Media MARC source
rdamedia
Media type code
  • c
Quality assurance targets
not applicable
Reformatting quality
unknown
Sound
unknown sound
Specific material designation
remote
System control number
  • ocn694732909
  • (OCoLC)694732909
Label
Medical device software verification, validation and compliance, David A. Vogel
Publication
Antecedent source
unknown
Bibliography note
Includes bibliographical references and index
Carrier category
online resource
Carrier category code
  • cr
Carrier MARC source
rdacarrier
Color
multicolored
Content category
text
Content type code
  • txt
Content type MARC source
rdacontent
Contents
  • 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
  • Machine generated contents note:
  • 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 -- ̂
  • 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
Dimensions
unknown
Extent
1 online resource (xix, 424 pages)
File format
unknown
Form of item
online
Isbn
9781596934221
Level of compression
unknown
Media category
computer
Media MARC source
rdamedia
Media type code
  • c
Quality assurance targets
not applicable
Reformatting quality
unknown
Sound
unknown sound
Specific material designation
remote
System control number
  • ocn694732909
  • (OCoLC)694732909

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