Tools

LEADER 04352cam a22004934a 4500

001 ocm62896385;

003 OCoLC;

005 20141212051226.0;

008 060104s2006 wiua b 001 0 eng ;

010 a| 2006000152;

020 a| 0873896742 (alk. paper);

020 a| 9780873896740 (alk. paper);

029 1 a| IG#b| 0873896742;

029 1 a| YDXCPb| 2240321;

029 1 a| AU@b| 000040063715;

035 a| (Sirsi) o62896385;

035 a| (OCoLC)62896385;

042 a| pcc;

049 a| EREE;

050 00 a| R856.6b| .F37 2006;

082 00 a| 610.2852| 22;

100 1 a| Faris, Thomas H.,d| 1968-=| ^A1207119;

245 10 a| Safe and sound software :b| creating an efficient and effective quality system for software medical device organizations /c| Thomas H. Faris.;

260 a| Milwaukee, Wis. :b| ASQ Quality Press,c| 2006.;

300 a| xiv, 354 pages :b| illustrations ;c| 23 cm +e| 1 CD-ROM (4 3/4 in.);

336 a| text2| rdacontent;

337 a| unmediated2| rdamedia;

338 a| volume2| rdacarrier;

504 a| Includes bibliographical references (p. 339-346) and index.;

505 0 a| 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.;

650 0 a| Medical instruments and apparatusv| Software.=| ^A3247;

650 0 a| Medical instruments and apparatus industry.=| ^A338720;

650 0 a| Computer software industry.=| ^A279955;

655 0 a| CD-ROMs.=| ^A366741;

856 41 3| Table of contentsu| http://www.loc.gov/catdir/toc/ecip066/2006000152.html;

994 a| C0b| ERE;

938 a| Ingramb| INGRn| 0873896742;

938 a| Baker and Taylorb| BTCPn| 2006000152;

938 a| YBP Library Servicesb| YANKn| 2240321;

938 a| Baker & Taylorb| BKTYc| 52.50d| 39.38i| 0873896742n| 0006705217s| active;

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998 a| 2263722;

999 a| R856.6 .F37 2006w| LCc| 1i| 30372015440081d| 2/26/2020e| 1/15/2020l| JGESm| JOYNERn| 1r| Ys| Yt| JGESBKu| 8/27/2010x| BOOKz| JSTACKSo| .STAFF. jmpl;

Safe and sound software : creating an efficient and effective quality system for software medical device organizations / Thomas H. Faris.

Author/creator	Faris, Thomas H., 1968-
Format	Book
Publication Info	Milwaukee, Wis. : ASQ Quality Press, 2006.
Description	xiv, 354 pages : illustrations ; 23 cm + 1 CD-ROM (4 3/4 in.)
Supplemental Content	Table of contents
Subjects	Medical instruments and apparatus--Software. Medical instruments and apparatus industry. Computer software industry.

Contents	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.
Bibliography note	Includes bibliographical references (p. 339-346) and index.
Genre/form	CD-ROMs.
LCCN	2006000152
ISBN	0873896742 (alk. paper)
ISBN	9780873896740 (alk. paper)

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Joyner	General Stacks	R856.6 .F37 2006	✔ Available	Place Hold

Safe and sound software : creating an efficient and effective quality system for software medical device organizations / Thomas H. Faris.

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