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

"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...