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9780873897402 - The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices von Daniel, Amiram (26 Ergebnisse)
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The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices, Second Edition
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hardcover. Zustand: Good.
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The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices, Second Edition
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Zustand: good. The item shows wear from consistent use, but it remains in good condition and works perfectly. All pages and cover are intact including the dust cover, if applicable . Spine may show signs of wear. Pages may include limited notes and highlighting. May NOT include discs, access code or other supplemental materials.
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The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices
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The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices
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The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices
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The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices
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The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices
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The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices
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Zustand: Good. Pages intact with minimal writing/highlighting. The binding may be loose and creased. Dust jackets/supplements are not included. Stock photo provided. Product includes identifying sticker. Better World Books: Buy Books. Do Good.
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Hardcover. Zustand: Good. Connecting readers with great books since 1972! Used textbooks may not include companion materials such as access codes, etc. May have some wear or writing/highlighting. We ship orders daily and Customer Service is our top priority!
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The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices, Second Edition
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Zustand: acceptable. This book is in acceptable condition and may have highlighting and or writing throughout. The actual cover image may not match the stock photo, dust jacket may be damaged or missing. Book may show internal and or external wear on spine or cover and may be slightly skewed or have creased pages. This is a used book so codes may be invalid or accompanying media may be missing. May be an Ex library book with stickers and stamps.
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The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices, Second Edition
Anbieter: Your Online Bookstore, Houston, TX, USA
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hardcover. Zustand: New.
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The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices, Second Edition
Anbieter: LeroBooks, Lawrenceville, GA, USA
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hardcover. Zustand: New. New book. Same day shipping with tracking info.
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The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices, Second Edition
Anbieter: Ria Christie Collections, Uxbridge, Vereinigtes Königreich
Verkäuferbewertung 5 von 5 Sternen
EUR 99,84
EUR 13,77 Versand
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The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices, Second Edition
Anbieter: Revaluation Books, Exeter, Vereinigtes Königreich
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EUR 127,81
EUR 14,37 Versand
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In den WarenkorbHardcover. Zustand: Brand New. 2nd edition. 336 pages. 9.10x5.90x1.00 inches. In Stock.
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The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices
Anbieter: PBShop.store US, Wood Dale, IL, USA
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HRD. Zustand: New. New Book. Shipped from UK. THIS BOOK IS PRINTED ON DEMAND. Established seller since 2000.
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The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices
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EUR 106,31
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In den WarenkorbHRD. Zustand: New. New Book. Delivered from our UK warehouse in 4 to 14 business days. THIS BOOK IS PRINTED ON DEMAND. Established seller since 2000.
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The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices
Anbieter: THE SAINT BOOKSTORE, Southport, Vereinigtes Königreich
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EUR 118,19
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In den WarenkorbHardback. Zustand: New. This item is printed on demand. New copy - Usually dispatched within 5-9 working days.
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The Fda and Worldwide Quality System Requirements Guidebook for Medical Devices
Sprache: Englisch
Verlag: American Society for Quality, 2008
ISBN 10: 0873897404 ISBN 13: 9780873897402
Anbieter: Majestic Books, Hounslow, Vereinigtes Königreich
Verkäuferbewertung 4 von 5 Sternen
EUR 138,34
EUR 7,47 Versand
Versand von Vereinigtes Königreich nach USAAnzahl: 4 verfügbar
In den WarenkorbZustand: New. Print on Demand pp. xxx + 304.
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The Fda and Worldwide Quality System Requirements Guidebook for Medical Devices
Sprache: Englisch
Verlag: American Society for Quality ASQ, 2008
ISBN 10: 0873897404 ISBN 13: 9780873897402
Zustand: New. Print on Demand pp. xxx + 304.
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The Fda and Worldwide Quality System Requirements Guidebook for Medical Devices
Sprache: Englisch
Verlag: American Society for Quality, 2008
ISBN 10: 0873897404 ISBN 13: 9780873897402
Anbieter: Biblios, Frankfurt am main, HESSE, Deutschland
Verkäuferbewertung 4 von 5 Sternen
Zustand: New. PRINT ON DEMAND pp. xxx + 304.
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Buch. Zustand: Neu. The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices | Amiram Daniel | Buch | Englisch | 2008 | ASQ Quality Press | EAN 9780873897402 | Verantwortliche Person für die EU: Libri GmbH, Europaallee 1, 36244 Bad Hersfeld, gpsr[at]libri[dot]de | Anbieter: preigu Print on Demand.
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The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices
Anbieter: AHA-BUCH GmbH, Einbeck, Deutschland
Verkäuferbewertung 5 von 5 Sternen
Buch. Zustand: Neu. nach der Bestellung gedruckt Neuware - Printed after ordering - ¿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, 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 combination 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. The organization of the guidebook is based on the order of the requirements in the QSReg. For each substantive requirement section there is: A verbatim statement of the QSReg requirement. A description of the comparable requirement in ISO 13485:2003, focusing on any additions to or differences from the requirements contained in the QSReg.Excerpts of the FDA responses to relevant comment groups contained in the Preamble to the QSReg. Excerpts from various FDA guidance documents related to quality management systems. A description of the relevant guidance contained in ISO/TR 14969:2004, focusing on any additions to or differences from the guidance in the Preamble and other FDA guidance documents, and, if useful, excerpts from relevant GHTF guidances. Authors' notes giving guidance derived from the authors' sixty years of regulatory compliance experience. This guidance book is meant as a resource to manufacturers of medical devices, providing up-to-date information concerning required and recommended quality system practices. It should be used as a companion to the regulations/standards themselves and texts on the specific processes and activities contained within the QMS.
