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: Umschulungswerkstätten für Siedler und Auswanderer > Bitterfeld; 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.; Quality control.; elektronické knihy; electronic books
• ISBN: 9781621982067; 1621982068; 9780873897402; 0873897404
• Physical Description: 1 online resource (xxx, 304 pages)
• Item Description: Includes index.; Revised edition of: FDA and worldwide quality system requirements guide book for medical devices / Kimberly A. Trautman. ©1997.
• Access: Plný text je dostupný pouze z IP adres počítačů Univerzity Tomáše Bati ve Zlíně nebo vzdáleným přístupem pro zaměstnance a studenty

"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."--Jacket