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Medical device design and regulation

Last Updated: 5-Mar-2015

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This guide is a starting point for research on design of medical devices and medical device regulation including resources for finding standards and materials.

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Sarah Lester
Sarah E Lester
Engineering Librarian for Outreach, Instruction and Electronic Resources
Engineering Library (Terman)
(650) 725-1018
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Subjects

Bioengineering
Materials science and engineering
Mechanical design
Medicine and health

Related guides

Bioengineering
Standards

Around Stanford

Bioengineering Department
School of Medicine
Biomedical Engineering group (BME)
BioDesign group

Article resources

Journals

Biomedical safety & standards [electronic resource].
Frederick, MD : Aspen Publishers Hagerstown, MD : Lippincott Williams & Wilkins
Stanford University Libraries » Online resource » eResource
Instrumentation science & technology.
New York, NY : Marcel Dekker, Inc., 1994-
SAL3 (off-campus storage) » Stacks » QD61 .C4 V.27 1999
Journal of medical devices [electronic resource].
Fairfield, NJ : American Society of Mechanical Engineers, 2007-
Stanford University Libraries » Online resource » eResource
Medical devices [electronic resource] : evidence and research.
[Auckland, N.Z.] : Dove Medical Press
Stanford University Libraries » Online resource » eResource
Proceedings of the Institution of Mechanical Engineers. Part H, Journal of engineering in medicine.
[London ; Birmingham, Ala. : Published for the Institution by Mechanical Engineering Publications Ltd.], c1989-
SAL3 (off-campus storage) » Stacks » R856 .A1 P76 F V.219 2005

Research databases

BIOSIS citation index [electronic resource].
[New York?] : Thomson Reuters.
Stanford University Libraries » Online resource » eResource
Engineering index.
New York [etc.]
SAL3 (off-campus storage) » Stacks » Z5851 .E62 V.95:PT.10 1996
IEEE Xplore [electronic resource].
[Piscataway, N.J.?] : IEEE, c1998-
Stanford University Libraries » Online resource » eResource
INSPEC [electronic resource].
[United States] : Institution of Electrical Engineers, INSPEC service, [19--]-
Stanford University Libraries » Online resource » eResource
MEDLINE [electronic resource].
[S.l.] : National Library of Medicine
Stanford University Libraries » Online resource » eResource
Medical eTrack [electronic resource].
New York, N.Y. : GlobalData.
Stanford University Libraries » Online resource » eResource
Medical device industry research.

Handbooks and encyclopedias

ISO 13485 : a complete guide to quality management in the medical device industry / Itay Abuhav.
Boca Raton : CRC Press/Taylor & Francis, c2012.
Engineering Library (Terman) » Stacks » R856.15 .A28 2012
Biomedical engineering and design handbook / Myer Kutz, editor.
2nd ed. New York : McGraw-Hill, c2009.
Engineering Library (Terman) » Stacks » R856.15 .S73 2009 V.1
Design of biomedical devices and systems / Paul H. King, Richard C. Fries.
2nd ed. Boca Raton, FL : CRC Press, c2009.
Engineering Library (Terman) » Stacks » R856 .K53 2009
Designing usability into medical products / Michael E. Wiklund, Stephen B. Wilcox ; foreword by Matthew B. Weinger.
Boca Raton : CRC Press, 2005.
Engineering Library (Terman) » Stacks » R856 .D473 2005
Encyclopedia of medical devices and instrumentation [electronic resource].
Hoboken, N.J. : Wiley InterScience, [2006]
Stanford University Libraries » Online resource » eResource
Medical device design : innovation from concept to market / Peter J. Ogrodnik.
1st ed. Amsterdam ; Boston : Elsevier/Academic Press, 2013.
Engineering Library (Terman) » Stacks » R856 .O37 2013
Medical device design for six sigma : a road map for safety and effectiveness / Basem S. El-Haik, Khalid S. Mekki.
Hoboken, NJ : Wiley-Interscience, c2008.
Engineering Library (Terman) » Stacks » R856.6 .E44 2008
Medical device quality assurance and regulatory compliance / Richard C. Fries.
New York : Marcel Dekker, c1998.
SAL3 (off-campus storage) » Stacks » R856.6 .F748 1998
The medical device R&D handbook / edited by Theodore R. Kucklick.
2nd ed. Boca Raton, Fl. : CRC Press, c2013.
Engineering Library (Terman) » Stacks » R856.15 .M43 2013
Medical device regulations [electronic resource] : global overview and guiding principles.
Geneva : World Health Organization, c2003.
Stanford University Libraries » Online resource » eResource
Reliable design of medical devices / Richard Fries.
2nd ed. Boca Raton : CRC/Taylor & Francis, 2006.
SAL3 (off-campus storage) » Stacks » R856.6 .F749 2006
Safety evaluation in the development of medical devices and combination products / Shayne C. Gad, Marian G. McCord.
3rd ed. New York : Informa Healthcare, c2008.
SAL3 (off-campus storage) » Stacks » R857 .M3 G33 2008

Materials, standards, and government regulations

Materials and standards

ASTM compass [electronic resource].
West Conshohocken, PA : ASTM international
Stanford University Libraries » Online resource » eResource
Full-text access to the 12,000+ ASTM standards collection.
IEEE Xplore [electronic resource].
[Piscataway, N.J.?] : IEEE, c1998-
Stanford University Libraries » Online resource » eResource
Full text access to IEEE and IEE standards. Also includes access to IEEE draft standards.
ASM medical materials database [electronic resource].
Materials Park, Ohio : ASM International ; Cambridge, United Kingdom : Granta
Stanford University Libraries » Online resource » eResource
Mechanical, physical, biological response, and drug compatibility properties for the materials and coatings used in medical devices.
ANSI Standards Connect [electronic resource].
[S.l.] : AAMI : ANSI : ASTM : DIN
Stanford University Libraries » Online resource » eResource
Full text medical device standards from various organizations: ANSI (ISO and IEC), ASTM, AAMI, and DIN

Government regulations

Code of Federal Regulations (CFR) Title 21
Of particular note are Title 21 Part 820 – quality system regulation, Aslo Title 21 Part 11 Electronic Records; Electronic signatures; and Parts 210 & 211 cGMP in manufacturing.  All can be accessed via eCFR
EUR-Lex
EU directives and updates on medical devices.