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Medical Device Software Verification, Validation, and Compliance.

Author: David A Vogel
Publisher: Norwood : Artech House, 2010.
Edition/Format:   eBook : Document : EnglishView all editions and formats
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  Read more...
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Genre/Form: Electronic books
Additional Physical Format: Print version:
Vogel, David A.
Medical Device Software Verification, Validation, and Compliance.
Norwood : Artech House, ©2010
Material Type: Document, Internet resource
Document Type: Internet Resource, Computer File
All Authors / Contributors: David A Vogel
ISBN: 9781596934238 1596934239
OCLC Number: 694729137
Description: 1 online resource (444 pages)
Contents: Medical Device Software Verification, Validation, and Compliance; Contents; Preface; Acknowledgments; PART I Background; Chapter 1 The Evolution of Medical Device Software Validation and the Need forThis Book; Chapter 2 Regulatory Background; Chapter 3 The FDA Software Validation Regulations and Why You Should Validate Software Anyway; Chapter 4 Organizational Considerations for Software Validation; Chapter 5 The Software (Development) Life Cycle; Chapter 6 Verification and Validation: What They Are, What They Are Not; Chapter 7 The Life Cycle Approach to Software Validation. Chapter 8 Supporting Activities that Span the Life Cycle: Risk ManagementChapter 9 Other Supporting Activities: Planning, Reviews, Configuration Management, and Defect Management; PART II Validation of Medical Device Software; Chapter 10 The Concept Phase Activities; Chapter 11 The Software Requirements Phase Activities; Chapter 12 The Design and Implementation Phase Activities; Chapter 13 The Testing Phase Activities; Chapter 14 The Maintenance Phase Validation Activities; PART III Validation of Nondevice Software; Chapter 15 Validating Automated Process Software: Background. Chapter 16 Planning Validation for Nondevice SoftwareChapter 17 Intended Use and the Requirements for Fulfilling Intended Use; Chapter 18 Risk Management and Configuration Management of Nondevice Sof tware:Activities that Span the Life Cycle; Chapter 19 Nondevice Testing Activities to Support Validation; Chapter 20 Nondevice Software Maintenance and Retirement Activities; About the Author; Index.

Abstract:

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 impor.

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