Medical Device Software Verification, Validation and Compliance

Front Cover
Artech House, 2011 - Biomedical engineering - 444 pages
HereOCOs 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 softwareOCOs 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, in compliance with regulations."
 

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Contents

Chapter 1 The Evolution of Medical Device Software Validation and the Need forThis Book
3
Chapter 2 Regulatory Background
13
Chapter 3 The FDA Software Validation Regulations and Why You Should Validate Software Anyway
27
Chapter 4 Organizational Considerations for Software Validation
37
Chapter 5 The Software Development Life Cycle
57
Chapter 6 Verification and Validation What They Are What They Are Not
75
Chapter 7 The Life Cycle Approach to Software Validation
89
Chapter 8 Supporting Activities that Span the Life Cycle Risk Management
105
Chapter 13 The Testing Phase Activities
253
Chapter 14 The Maintenance Phase Validation Activities
305
PART III Validation of Nondevice Software
323
Chapter 15 Validating Automated Process Software Background
325
Chapter 16 Planning Validation for Nondevice Software
345
Chapter 17 Intended Use and the Requirements for Fulfilling Intended Use
363
Chapter 18 Risk Management and Configuration Management of Nondevice Sof twareActivities that Span the Life Cycle
375
Chapter 19 Nondevice Testing Activities to Support Validation
393

Chapter 9 Other Supporting Activities Planning Reviews Configuration Managementand Defect Management
143
PART II Validation of Medical Device Software
191
Chapter 10 The Concept Phase Activities
193
Chapter 11 The Software Requirements Phase Activities
207
Chapter 12 The Design and Implementation Phase Activities
233
Chapter 20 Nondevice Software Maintenance and Retirement Activities
401
About the Author
409
Index
411
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