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...

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Bibliographic Details
Main Author: Daniel, Amiram.
Other Authors: Kimmelman, Ed., Trautman, Kimberly A., 1964-
Format: eBook
Language: English
Published: Milwaukee, Wis. : ASQ Quality Press, 2008.
Edition: 2nd ed.
Subjects:
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.
Quality control.
elektronické knihy
electronic books
ISBN: 9781621982067
1621982068
9780873897402
0873897404
Physical Description: 1 online resource (xxx, 304 pages)

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Table of contents

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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 

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