9780692835418 - design controls, risk management & process validation for medical device professionals: a comprehensive handbook for interpreting and implementing design control regulation von geckler, mr. vernon m (3 Ergebnisse)
Sprache: Englisch
Verlag: Design Controls, Risk Management and Process Validation for Medical Device Professionals 2017
- Softcover
Anbieter: World of Books (was SecondSale), Montgomery, IL, USAWorld of Books (was SecondSale)
Verkäufer/-in kontaktierenVerkäufer/-in mit 5 SternenZustand: Gebraucht - Ausreichend
EUR 125,78
Versand nach gratisVersand innerhalb von USAAnzahl: 1 verfügbar
Zustand: Acceptable. Item in acceptable condition! Textbooks may not include supplemental items i.e. CDs, access codes etc.
- Softcover
Anbieter: moluna, Greven, , Deutschlandmoluna
Verkäufer/-in kontaktierenVerkäufer/-in mit 5 SternenZustand: Neu
EUR 159,33
EUR 48,99 VersandVersand von Deutschland nach USAAnzahl: Mehr als 20 verfügbar
Zustand: New.
Verlag: Amazon Digital Services LLC - KDP Print US
- Softcover
Anbieter: AHA-BUCH GmbH, Einbeck, DeutschlandAHA-BUCH GmbH
Verkäufer/-in kontaktierenVerkäufer/-in mit 5 SternenZustand: Neu
EUR 198,55
EUR 65,08 VersandVersand von Deutschland nach USAAnzahl: 2 verfügbar
Taschenbuch. Zustand: Neu. Neuware - This handbook is ranked as a best seller and provides the most up to date resource currently available for interpreting and understanding design controls. This handbook is the most exhaustive resource ever written about FDA design controls for medical devices with a collection of all applicab…le regulations and real-world examples. Four-hundred & forty, 8.5' X 11' pages provides an extensive evaluation of FDA 21 CFR 820 and is cross-referenced with ISO 13485 to provide readers with a broad and in depth review of practical design control implementation techniques. This handbook also covers basic, intermediate and advanced design control topics and is an ideal resource for implementing new design control processes or upgrading existing process into medical device quality systems. This critical resource also specifically outlines key topics which will allow quality managers and medical device developers to improve compliance quickly to pass internal and external audits and FDA inspections. The author breaks down the regulation line by line and provides a detailed interpretation by using supportive evidence from the FDA design control guidance and the quality systems preamble. Numerous examples, case studies, best practices, 70+ figures and 45+ tables provide practical implementation techniques which are based on the author's extensive experience launching numerous medical device products and by integrating industry consultant expertise. As an added bonus, web access to downloadable and editable design control documents are included with this purchase. In addition, bonus chapters include: explanation of medical device classification, compliance to design controls, risk management, and the design control quality system preamble. 30-50 pages are dedicated to each of the major design control topics: Design and Development Planning, Design Input, Design Output, Design Transfer, Design Verification, Design Validation, Design Change and Design History File.
