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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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor principal: Daniel, Amiram
Otros Autores: Kimmelman, Ed, Trautman, Kimberly A., 1964-
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Milwaukee, Wis. : ASQ Quality Press, 2008.
Edición:2nd ed.
Temas:
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.
Device Approval > legislation & jurisprudence
Equipment and Supplies > standards
Equipment Safety > standards
Government Regulation
Guidelines as Topic
Equipment and Supplies > standards > United States > Guideline.
Guidelines as Topic > United States > Guideline.
Device Approval > legislation & jurisprudence > United States > Guideline.
Government Regulation > United States > Guideline.
Quality Control > United States > Guideline.
Equipment Safety > standards > United States > Guideline.
Médecine > Appareils et instruments > Industrie > États-Unis > Qualité > Contrôle.
Médecine > Appareils et instruments > Industrie > Qualité > Contrôle.
Medizinisches Gerät
Qualitätskontrolle
United States.
USA
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