Data Portal @ linkeddatafragments.org

Matches in Library of Congress for { <http://lccn.loc.gov/2006000152> ?p ?o. }

• 2006000152 contributor B10405408.
• 2006000152 created "2006.".
• 2006000152 date "2006".
• 2006000152 date "2006.".
• 2006000152 dateCopyrighted "2006.".
• 2006000152 description "Chapter 1. Operational requirements for software medical device manufacturers -- Introduction -- Software lives -- Control of software defects -- Software medical devices -- Medical device regulation -- Health and safety risk management -- Primary business operational objectives -- Business quality objectives -- ISO quality system standards -- Resultant web of regulatory and quality requirements -- Establishing a comprehensive quality system for a software medical device organization -- Chapter 2. Ramifications of software defects -- Introduction -- Examples of serious ramifications of software defects -- Impact on customers -- Impact on software development organizations -- Potential safety ramifications of medical software defects -- Threat of small medical device manufacturers -- Summary -- Chapter 3. Software quality -- Introduction -- The poor statistics of software quality -- Defining quality -- Defining software quality -- Summary -- Chapter 4. Software design and development -- Introduction -- Failure to follow reasonable practices -- Quality culture -- Software design and development procedures -- Summary -- Chapter 5. Safety risk management -- Introduction -- Beneficial and efficacious use -- Product safety risk management -- Risk management standards -- Summary -- Chapter 6. FDA regulation -- Introduction -- The FDA -- Regulation of software -- Establishment registration -- Premarket product clearance -- Incident reporting requirements -- Device labeling -- Quality system regulations -- FDA and compliance -- Summary -- Chapter 7. International requirements -- Introduction -- CE marking -- Global harmonization -- Summary -- Chapter 8. ISO quality system standards -- Introduction -- The international organization for standardization -- ISO 9001 -- ISO/IEC 90003:2004 -- ISO 13485:2003 -- Summary -- Chapter 9. Other compliance requirements -- Introduction -- HIPAA -- Sarbanes-Oxley Act -- Integration of consistent operational subsystems -- Summary -- Chapter 10. Final thoughts on implementation -- Quality assurance-fighting the good fight -- Appendix A. Software medical device quality system guidelines -- Introduction -- Quality system requirements -- Requirement traceability matrix -- Appendix B. Outline of ISO 9126 -- Appendix C. Outline of ISO 14971:2000 -- Appendix D. Outline of the quality system regulations, 21 CFR Part 820 -- Appendix E. Outline of the requirements of ISO 9001:2000.".
• 2006000152 description "Includes bibliographical references (p. 339-346) and index.".
• 2006000152 extent "xiv, 354 p. :".
• 2006000152 identifier "0873896742 (alk. paper)".
• 2006000152 identifier "9780873896740".
• 2006000152 identifier 2006000152.html.
• 2006000152 issued "2006".
• 2006000152 issued "2006.".
• 2006000152 language "eng".
• 2006000152 publisher "Milwaukee, Wis. : ASQ Quality Press,".
• 2006000152 subject "610.285 22".
• 2006000152 subject "Computer software industry.".
• 2006000152 subject "Medical instruments and apparatus Software.".
• 2006000152 subject "Medical instruments and apparatus industry.".
• 2006000152 subject "R856.6 .F37 2006".
• 2006000152 tableOfContents "Chapter 1. Operational requirements for software medical device manufacturers -- Introduction -- Software lives -- Control of software defects -- Software medical devices -- Medical device regulation -- Health and safety risk management -- Primary business operational objectives -- Business quality objectives -- ISO quality system standards -- Resultant web of regulatory and quality requirements -- Establishing a comprehensive quality system for a software medical device organization -- Chapter 2. Ramifications of software defects -- Introduction -- Examples of serious ramifications of software defects -- Impact on customers -- Impact on software development organizations -- Potential safety ramifications of medical software defects -- Threat of small medical device manufacturers -- Summary -- Chapter 3. Software quality -- Introduction -- The poor statistics of software quality -- Defining quality -- Defining software quality -- Summary -- Chapter 4. Software design and development -- Introduction -- Failure to follow reasonable practices -- Quality culture -- Software design and development procedures -- Summary -- Chapter 5. Safety risk management -- Introduction -- Beneficial and efficacious use -- Product safety risk management -- Risk management standards -- Summary -- Chapter 6. FDA regulation -- Introduction -- The FDA -- Regulation of software -- Establishment registration -- Premarket product clearance -- Incident reporting requirements -- Device labeling -- Quality system regulations -- FDA and compliance -- Summary -- Chapter 7. International requirements -- Introduction -- CE marking -- Global harmonization -- Summary -- Chapter 8. ISO quality system standards -- Introduction -- The international organization for standardization -- ISO 9001 -- ISO/IEC 90003:2004 -- ISO 13485:2003 -- Summary -- Chapter 9. Other compliance requirements -- Introduction -- HIPAA -- Sarbanes-Oxley Act -- Integration of consistent operational subsystems -- Summary -- Chapter 10. Final thoughts on implementation -- Quality assurance-fighting the good fight -- Appendix A. Software medical device quality system guidelines -- Introduction -- Quality system requirements -- Requirement traceability matrix -- Appendix B. Outline of ISO 9126 -- Appendix C. Outline of ISO 14971:2000 -- Appendix D. Outline of the quality system regulations, 21 CFR Part 820 -- Appendix E. Outline of the requirements of ISO 9001:2000.".
• 2006000152 title "Safe and sound software : creating an efficient and effective quality system for software medical device organizations / Thomas H. Faris.".
• 2006000152 type "text".