Medical device software verification, validation and compliance
Record details
- ISBN: 1523117397
- ISBN: 9781523117390
- ISBN: 1596934239
- ISBN: 9781596934238
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Physical Description:
1 online resource (xix, 424 pages)
remote - Publisher: Boston : Artech House, ©2011.
Content descriptions
Bibliography, etc. Note: | Includes bibliographical references and index. |
Formatted Contents Note: | 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 -- ^ |
Restrictions on Access Note: | NLC staff and students only. |
Source of Description Note: | Print version record. |
Search for related items by subject
Subject: | Software -- standards Device Approval -- standards Software Validation Computer software -- Quality control Software engineering Medical instruments and apparatus -- Software |
Genre: | Electronic books. Software. Electronic books. |