The FDA and worldwide quality system requirements guidebook for medical devices
Saved in:
| Main Author | |
|---|---|
| Other Authors | , |
| Format | Electronic eBook |
| Language | English |
| Published |
Milwaukee, Wis. :
ASQ Quality Press,
2008.
|
| Edition | 2nd ed. |
| Subjects | |
| Online Access | Full text |
| ISBN | 9781621982067 1621982068 9780873897402 0873897404 |
| Physical Description | 1 online resource (xxx, 304 pages) |
Cover
| LEADER | 00000cam a2200000 a 4500 | ||
|---|---|---|---|
| 001 | kn-ocn838150472 | ||
| 003 | OCoLC | ||
| 005 | 20240717213016.0 | ||
| 006 | m o d | ||
| 007 | cr cn||||||||| | ||
| 008 | 130411s2008 wiu o 001 0 eng d | ||
| 040 | |a KNOVL |b eng |e pn |c KNOVL |d OCLCO |d COO |d ZCU |d KNOVL |d OCLCF |d OCLCO |d KNOVL |d E7B |d EBLCP |d OCLCQ |d STF |d OCLCQ |d AZK |d COCUF |d OCLCQ |d MOR |d CCO |d PIFAG |d MERUC |d OCLCQ |d U3W |d BUF |d OCLCO |d MERER |d OCLCQ |d CEF |d NRAMU |d RRP |d ICG |d VT2 |d AU@ |d OCLCO |d WYU |d OCLCQ |d OCLCO |d OCLCQ |d OCLCA |d TKN |d OCLCQ |d DKC |d OCLCO |d OCLCQ |d ERF |d OCLCQ |d OCLCA |d OCLCQ |d OCLCA |d MM9 |d OCLCQ |d TUHNV |d OCLCO |d OCLCA |d OCLCQ |d OCLCO |d OCLCQ |d UKAHL |d INARC |d OCLCO |d OCLCL |d OCLCQ |d OCLCO | ||
| 020 | |a 9781621982067 |q (electronic bk.) | ||
| 020 | |a 1621982068 |q (electronic bk.) | ||
| 020 | |z 9780873897402 | ||
| 020 | |z 0873897404 | ||
| 035 | |a (OCoLC)838150472 |z (OCoLC)893681432 |z (OCoLC)961542709 | ||
| 043 | |a n-us--- | ||
| 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. ©1997. | ||
| 506 | |a Plný text je dostupný pouze z IP adres počítačů Univerzity Tomáše Bati ve Zlíně nebo vzdáleným přístupem pro zaměstnance a studenty | ||
| 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 | |
| 590 | |a Knovel |b Knovel (All titles) | ||
| 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 | 0 | |a Quality control. | |
| 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=https://app.knovel.com/hotlink/toc/id:kpFDAWQSR1/fda-and-worldwide?kpromoter=marc |y Full text |