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...
Saved in:
| Main Author: | |
|---|---|
| Other Authors: | , |
| Format: | eBook |
| Language: | English |
| Published: |
Milwaukee, Wis. :
ASQ Quality Press,
2008.
|
| Edition: | 2nd ed. |
| Subjects: | |
| ISBN: | 9781621982067 |
| Physical Description: | 1 online zdroj (xxx, 304 p.) |
Cover
Table of contents
| LEADER | 03132cam a2200469 a 4500 | ||
|---|---|---|---|
| 001 | 74010 | ||
| 003 | CZ ZlUTB | ||
| 005 | 20240911211913.0 | ||
| 006 | m d | ||
| 007 | cr un | ||
| 008 | 130411s2008 wiu s 001 0 eng d | ||
| 020 | |a 9781621982067 |q (ebook) | ||
| 035 | |a (OCoLC)838150472 | ||
| 040 | |a KNOVL |c KNOVL |d OCLCO |d COO |d ZCU |d KNOVL |d OCLCF | ||
| 043 | |a n-us--- | ||
| 100 | 1 | |a Daniel, Amiram. | |
| 245 | 1 | 4 | |a The FDA and worldwide quality system requirements guidebook for medical devices |h [elektronický zdroj] / |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 zdroj (xxx, 304 p.) | ||
| 500 | |a Includes index. | ||
| 500 | |a Rev. ed. 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."--BOOK JACKET. | |
| 588 | |a Description based on print version record. | ||
| 506 | |a Plný text je dostupný pouze z IP adres počítačů Univerzity Tomáše Bati ve Zlíně nebo vzdáleným přístupem pro zaměstnance a studenty univerzity | ||
| 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. | |
| 651 | 7 | |a USA. |0 (DE-588c)4078704-7 |2 swd | |
| 651 | 7 | |a United States. |2 fast |0 (OCoLC)fst01204155 | |
| 655 | 7 | |a elektronické knihy |7 fd186907 |2 czenas | |
| 655 | 9 | |a electronic books |2 eczenas | |
| 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://proxy.k.utb.cz/login?url=http://app.knovel.com/web/toc.v/cid:kpFDAWQSR1 |y Plný text |
| 992 | |a BK |c KNOVEL | ||
| 999 | |c 74010 |d 74010 | ||
| 993 | |x NEPOSILAT |y EIZ | ||
Save to List
Cite this
Export Record
Email this