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The FDA and worldwide quality system requirements guidebook for medical devices /
"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...
| Clasificación: | Libro Electrónico |
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| Autor principal: | |
| Otros Autores: | , |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Milwaukee, Wis. :
ASQ Quality Press,
2008.
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| Edición: | 2nd ed. |
| Temas: | |
| Acceso en línea: | Texto completo |
| Sumario: | "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. |
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| Notas: | Includes index. Revised edition of: FDA and worldwide quality system requirements guide book for medical devices / Kimberly A. Trautman. c1997. |
| Descripción Física: | 1 online resource (xxx, 304 pages) |
| ISBN: | 9781621982067 1621982068 |