The FDA and worldwide quality system requirements guidebook for medical devices

• Main Author: Daniel, Amiram.
• Other Authors: Kimmelman, Ed., Trautman, Kimberly A., 1964-
• Format: eBook
• Language: English
• Published: Milwaukee, Wis. : ASQ Quality Press, 2008.
• Edition: 2nd ed.
• Subjects: Medical instruments and apparatus industry > Law and legislation > United States.; Quality control > Law and legislation > United States.; Medical instruments and apparatus industry > United States > Quality control.; Medical instruments and apparatus industry > Law and legislation.; Quality control > Law and legislation.; Medical instruments and apparatus industry > Quality control.; USA.; United States.; elektronické knihy; electronic books
• ISBN: 9781621982067
• Physical Description: 1 online zdroj (xxx, 304 p.)
• Item Description: Includes index.; Rev. ed. of: FDA and worldwide quality system requirements guide book for medical devices / Kimberly A. Trautman. c1997.
• Access: Plný text je dostupný pouze z IP adres počítačů Univerzity Tomáše Bati ve Zlíně nebo vzdáleným přístupem pro zaměstnance a studenty univerzity

"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.