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001 9781351261487
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008 190805s2020 flu ob 001 0 eng d
040 _aOCoLC-P
_beng
_erda
_epn
_cOCoLC-P
020 _a9781351261487
_q(electronic bk.)
020 _a1351261487
_q(electronic bk.)
020 _z9780815365525
020 _a9781351261463
_q(electronic bk. : EPUB)
020 _a1351261460
_q(electronic bk. : EPUB)
020 _a9781351261456
_q(electronic bk. : Mobipocket)
020 _a1351261452
_q(electronic bk. : Mobipocket)
020 _a9781351261470
_q(electronic bk. : PDF)
020 _a1351261479
_q(electronic bk. : PDF)
035 _a(OCoLC)1111577626
035 _a(OCoLC-P)1111577626
050 4 _aR856.A2
_bT45 2020eb
082 0 4 _a610.28
_223
100 1 _aTeixeira, Marie B.,
_d1965-
_eauthor.
245 1 0 _aDesign controls for the medical device industry /
_cMarie B. Teixeira.
250 _aThird edition.
264 1 _aBoca Raton, FL :
_bCRC Press,
_c2020.
300 _a1 online resource (xiv, 248 pages).
336 _atext
_btxt
_2rdacontent
337 _acomputer
_bc
_2rdamedia
338 _aonline resource
_bcr
_2rdacarrier
505 0 _aIntroduction. Device classification. Overview of design controls. Design and development planning. Design inputs: Part I. Design inputs: Part II. Design outputs. Design review. Design verification. Risk management. Design validation. Biocompatibility. Design transfer. Design change. Design history file. The FDA inspection technique. Appendix A: Design controls procedure. Appendix B: Design input document. Appendix C: Product claims sheet. Appendix D: Input/Output design traceability matrix. Appendix E: Project approval form. Appendix F: Design phase review meeting record. Appendix G: Risk analysis. Appendix H: Clinical evaluation report. Appendix I: Design transfer checklist. Appendix J: Design change form. Appendix K: Approval for sale form. Appendix L: Engineering change order form.
520 _aThis third edition provides a substantial comprehensive review of the latest design control requirements, as well as proven tools and techniques to ensure a company's design control program evolves in accordance with current industry practice. It assists in the development of an effective design control program that not only satisfies the US FDA Quality Systems Regulation (QSR) and 13485:2016 standards, but also meets today's Notified Body Auditors' and FDA Investigators' expectations. The book includes a review of the design control elements such as design planning, input, output, review, verification, validation, change, transfer, and history, as well as risk management inclusive of human factors and usability, biocompatibility, the FDA Quality System Inspection Technique (QSIT) for design controls, and medical device regulations and classes in the US, Canada, and Europe. Practical advice, methods and appendixes are provided to assist with implementation of a compliant design control program and extensive references are provided for further study. This third edition: Examines new coverage of ISO 13485-2016 design control requirements Explores proven techniques and methods for compliance Contributes fresh templates for practical implementation Provides updated chapters with additional details for greater understanding and compliance Offers an easy to understand breakdown of design control requirements Reference to MDSAP design control requirements
588 _aOCLC-licensed vendor bibliographic record.
650 0 _aMedical instruments and apparatus
_xDesign and construction.
650 0 _aMedical instruments and apparatus industry.
856 4 0 _3Taylor & Francis
_uhttps://www.taylorfrancis.com/books/9781351261487
856 4 2 _3OCLC metadata license agreement
_uhttp://www.oclc.org/content/dam/oclc/forms/terms/vbrl-201703.pdf
999 _c130153
_d130153