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|a Daniel, Amiram.
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|a The FDA and worldwide quality system requirements guidebook for medical devices
|h [elektronický zdroj] /
|c compiled and written by Amiram Daniel & Ed Kimmelman.
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| 250 |
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|a 2nd ed.
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| 260 |
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|a Milwaukee, Wis. :
|b ASQ Quality Press,
|c 2008.
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| 300 |
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|a 1 online zdroj (xxx, 304 p.)
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| 500 |
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|a Includes index.
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| 500 |
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|a Rev. ed. of: FDA and worldwide quality system requirements guide book for medical devices / Kimberly A. Trautman. c1997.
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| 520 |
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|a "This new and expanded second edition maintains the organizational approach of the first and includes the requirements and guidance contained in the Quality System Regulation (QSReg), the ISO 13485:2003 standard, and the ISO/TR 14969:2004 guidance document, and, as appropriate, a number of the FDA and Global Harmonization Task Force (GHTF) guidance documents." "This second edition also addresses a number of additional topics, such as the incorporation of risk management into the medical device organization's QMS, QMS issues related to continuation products, the key process interactions within a QMS, effective presentation of and advocacy for a QMS during FDA inspections and third-party assessments, and future FDA compliance and standards activities."--BOOK JACKET.
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|a Description based on print version record.
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|a Plný text je dostupný pouze z IP adres počítačů Univerzity Tomáše Bati ve Zlíně nebo vzdáleným přístupem pro zaměstnance a studenty univerzity
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