The FDA and worldwide quality system requirements guidebook for medical devices

The FDA and worldwide quality system requirements guidebook for medical devices /

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"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...

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Bibliographic Details
Main Author: Daniel, Amiram
Other Authors: Kimmelman, Ed, Trautman, Kimberly A., 1964-
Format: Electronic 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.
Quality control.
Device Approval > legislation & jurisprudence
Equipment and Supplies > standards
Equipment Safety > standards
Government Regulation
Guidelines as Topic
Quality Control
quality control.
United States
Guideline
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