Design controls for the medical device industry

"Design control is a key element of a company's quality management system and is mandated by the U.S. FDA's Quality System Regulation under article 820.30 for most medical devices. Medical device companies wishing to comply with ISO 13485 to meet international requirements are also su...

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Bibliographic Details
Main Author: Teixeira, Marie B., 1965- (Author)
Format: eBook
Language: English
Published: Boca Raton : Taylor & Francis, [2013]
Edition: Second edition.
Subjects:
Medical instruments and apparatus > Design and construction.
Medical instruments and apparatus industry.
Quality control.
elektronické knihy
electronic books
ISBN: 9781466503557
1466503556
9781628707120
1628707127
9781466503540
1466503548
Physical Description: 1 online resource

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Table of contents

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020 |a 9781466503557  |q (electronic bk.) 
020 |a 1466503556  |q (electronic bk.) 
020 |a 9781628707120  |q (electronic bk.) 
020 |a 1628707127  |q (electronic bk.) 
020 |z 9781466503540 
020 |z 1466503548 
035 |a (OCoLC)862077197  |z (OCoLC)862828730  |z (OCoLC)869311307  |z (OCoLC)1004609641  |z (OCoLC)1009345816 
043 |a n-us--- 
100 1 |a Teixeira, Marie B.,  |d 1965-  |e author.  |1 https://id.oclc.org/worldcat/entity/E39PCjF3HrpMGCjGrXfpKRkwhb 
245 1 0 |a Design controls for the medical device industry /  |c Marie B. Teixeira. 
250 |a Second edition. 
264 1 |a Boca Raton :  |b Taylor & Francis,  |c [2013] 
264 4 |c ©20 
264 4 |c ©2014 
300 |a 1 online resource 
336 |a text  |b txt  |2 rdacontent 
337 |a computer  |b c  |2 rdamedia 
338 |a online resource  |b cr  |2 rdacarrier 
504 |a Includes bibliographical references and index. 
506 |a Plný text je dostupný pouze z IP adres počítačů Univerzity Tomáše Bati ve Zlíně nebo vzdáleným přístupem pro zaměstnance a studenty 
520 |a "Design control is a key element of a company's quality management system and is mandated by the U.S. FDA's Quality System Regulation under article 820.30 for most medical devices. Medical device companies wishing to comply with ISO 13485 to meet international requirements are also subject to design control requirements. This second edition of a bestselling book expands and updates all chapters with detail on current design control requirements, more examples, and further explanation and clarification of the requirements. The book also addresses device risk and classification, and covers risk management in its own chapter. Appendices have also been revised"--Provided by publisher 
505 0 |a 1. Introduction -- 2. Device classification -- 3. Overview of design controls -- 4. Design and development planning -- 5. Design inputs : part I -- 6. Design inputs : part II -- 7. Design outputs -- 8. Design review -- 9. Design verification -- 10. Risk management -- 11. Design validation -- 12. Biocompatibility -- 13. Design transfer -- 14. Design change -- 15. Design history file -- 16. The FDA inspection technique. 
590 |a Knovel  |b Knovel (All titles) 
650 0 |a Medical instruments and apparatus  |x Design and construction. 
650 0 |a Medical instruments and apparatus industry. 
650 0 |a Quality control. 
655 7 |a elektronické knihy  |7 fd186907  |2 czenas 
655 9 |a electronic books  |2 eczenas 
776 0 8 |i Print version:  |a Teixeira, Marie B., 1965-  |t Design controls for the medical device industry.  |b Second edition  |z 9781466503540  |w (DLC) 2013038095  |w (OCoLC)754730274 
856 4 0 |u https://proxy.k.utb.cz/login?url=https://app.knovel.com/hotlink/toc/id:kpDCMDIE01/design-controls-for?kpromoter=marc  |y Full text 

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