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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 |
|---|---|
| Autor principal: | |
| Otros Autores: | , |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Milwaukee, Wis. :
ASQ Quality Press,
2008.
|
| Edición: | 2nd ed. |
| Temas: | |
| Acceso en línea: | Texto completo |
MARC
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| 050 | 4 | |a KF3827.M4 |b T73 2008eb | |
| 060 | 4 | |a 2009 B-080 | |
| 060 | 4 | |a W 26 |b D184f 2008 | |
| 082 | 0 | 4 | |a 344.7304/2 |2 22 |
| 084 | |a XL 9300 |2 rvk | ||
| 049 | |a UAMI | ||
| 100 | 1 | |a Daniel, Amiram. | |
| 245 | 1 | 4 | |a The FDA and worldwide quality system requirements guidebook for medical devices / |c compiled and written by Amiram Daniel & Ed Kimmelman. |
| 250 | |a 2nd ed. | ||
| 260 | |a Milwaukee, Wis. : |b ASQ Quality Press, |c 2008. | ||
| 300 | |a 1 online resource (xxx, 304 pages) | ||
| 336 | |a text |b txt |2 rdacontent | ||
| 337 | |a computer |b c |2 rdamedia | ||
| 338 | |a online resource |b cr |2 rdacarrier | ||
| 500 | |a Includes index. | ||
| 500 | |a Revised edition of: FDA and worldwide quality system requirements guide book for medical devices / Kimberly A. Trautman. c1997. | ||
| 520 | 1 | |a "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. | |
| 588 | 0 | |a Print version record. | |
| 590 | |a Knovel |b ACADEMIC - Biochemistry, Biology & Biotechnology | ||
| 610 | 2 | 7 | |a Umschulungswerkstätten für Siedler und Auswanderer |g Bitterfeld |2 gnd |
| 650 | 0 | |a Medical instruments and apparatus industry |x Law and legislation |z United States. | |
| 650 | 0 | |a Quality control |x Law and legislation |z United States. | |
| 650 | 0 | |a Medical instruments and apparatus industry |z United States |x Quality control. | |
| 650 | 0 | |a Medical instruments and apparatus industry |x Law and legislation. | |
| 650 | 0 | |a Quality control |x Law and legislation. | |
| 650 | 0 | |a Medical instruments and apparatus industry |x Quality control. | |
| 650 | 1 | 2 | |a Device Approval |x legislation & jurisprudence |
| 650 | 1 | 2 | |a Equipment and Supplies |x standards |
| 650 | 2 | 2 | |a Equipment Safety |x standards |
| 650 | 2 | 2 | |a Government Regulation |
| 650 | 2 | 2 | |a Guidelines as Topic |
| 650 | 1 | 2 | |a Equipment and Supplies |x standards |z United States |v Guideline. |
| 650 | 2 | 2 | |a Guidelines as Topic |z United States |v Guideline. |
| 650 | 1 | 2 | |a Device Approval |x legislation & jurisprudence |z United States |v Guideline. |
| 650 | 2 | 2 | |a Government Regulation |z United States |v Guideline. |
| 650 | 2 | 2 | |a Quality Control |z United States |v Guideline. |
| 650 | 2 | 2 | |a Equipment Safety |x standards |z United States |v Guideline. |
| 650 | 6 | |a Médecine |x Appareils et instruments |x Industrie |z États-Unis |x Qualité |x Contrôle. | |
| 650 | 6 | |a Médecine |x Appareils et instruments |x Industrie |x Qualité |x Contrôle. | |
| 650 | 7 | |a Medical instruments and apparatus industry |x Law and legislation. |2 fast |0 (OCoLC)fst01014249 | |
| 650 | 7 | |a Medical instruments and apparatus industry |x Quality control. |2 fast |0 (OCoLC)fst01014253 | |
| 650 | 7 | |a Quality control |x Law and legislation. |2 fast |0 (OCoLC)fst01084988 | |
| 651 | 7 | |a United States. |2 fast |0 (OCoLC)fst01204155 | |
| 650 | 7 | |a Medizinisches Gerät |2 gnd | |
| 650 | 7 | |a Qualitätskontrolle |2 gnd | |
| 651 | 7 | |a USA |2 gnd | |
| 700 | 1 | |a Kimmelman, Ed. | |
| 700 | 1 | |a Trautman, Kimberly A., |d 1964- |t FDA and worldwide quality system requirements guide book for medical devices. | |
| 776 | 0 | 8 | |i Print version: |a Daniel, Amiram. |t FDA and worldwide quality system requirements guidebook for medical devices. |b 2nd ed. |d Milwaukee, Wis. : ASQ Quality Press, 2008 |z 9780873897402 |w (DLC) 2008013052 |w (OCoLC)214066132 |
| 856 | 4 | 0 | |u https://appknovel.uam.elogim.com/kn/resources/kpFDAWQSR1/toc |z Texto completo |
| 938 | |a Internet Archive |b INAR |n fdaworldwidequal0000dani | ||
| 938 | |a Askews and Holts Library Services |b ASKH |n AH41064457 | ||
| 938 | |a ProQuest Ebook Central |b EBLB |n EBL3002585 | ||
| 938 | |a ebrary |b EBRY |n ebr10929539 | ||
| 994 | |a 92 |b IZTAP | ||