9780692835418 - design controls, risk management & process validation for medical device professionals: a comprehensive handbook for interpreting and implementing design control regulation de geckler, mr. vernon m (16 resultados)
Idioma: Inglés
Editorial: Design Controls, Risk Management and Process Validation for Medical Device Professionals, 2017
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Librería: World of Books (was SecondSale), Montgomery, IL, Estados Unidos de AmericaWorld of Books (was SecondSale)
Contactar con el vendedorVendedor de 5 estrellasCondición: Usado - Bueno
EUR 74,04
Gastos de envío gratisSe envía dentro de Estados Unidos de AmericaCantidad disponible: 1 disponibles
Condición: Very Good. Item in very good condition! Textbooks may not include supplemental items i.e. CDs, access codes etc.
Idioma: Inglés
Editorial: Design Controls, Risk Management and Process Validation for Medical Device Professionals, 2017
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Librería: World of Books (was SecondSale), Montgomery, IL, Estados Unidos de AmericaWorld of Books (was SecondSale)
Contactar con el vendedorVendedor de 5 estrellasCondición: Usado - Regular
EUR 74,04
Gastos de envío gratisSe envía dentro de Estados Unidos de AmericaCantidad disponible: 1 disponibles
Condición: Acceptable. Item in acceptable condition! Textbooks may not include supplemental items i.e. CDs, access codes etc.
Idioma: Inglés
Editorial: Design Controls, Risk Management and Process Validation for Medical Device Professionals, 2017
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Librería: World of Books Inc, Montgomery, IL, Estados Unidos de AmericaWorld of Books Inc
Contactar con el vendedorVendedor de 2 estrellasCondición: Usado - Bueno
EUR 77,73
Gastos de envío gratisSe envía dentro de Estados Unidos de AmericaCantidad disponible: 1 disponibles
Paperback. Condición: Very Good. 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 applicable r…egulations 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.
Idioma: Inglés
Editorial: Design Controls, Risk Management and Process Validation for Medical Device Professionals, 2017
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Librería: World of Books Inc, Montgomery, IL, Estados Unidos de AmericaWorld of Books Inc
Contactar con el vendedorVendedor de 2 estrellasCondición: Usado - Regular
EUR 77,73
Gastos de envío gratisSe envía dentro de Estados Unidos de AmericaCantidad disponible: 1 disponibles
Paperback. Condición: Fair. 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 applicable regula…tions 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.
Idioma: Inglés
Editorial: Design Controls, Risk Management and Process Validation for Medical Device Professionals, 2017
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Librería: GreatBookPrices, Columbia, MD, Estados Unidos de AmericaGreatBookPrices
Contactar con el vendedorVendedor de 5 estrellasCondición: Nuevo
EUR 150,89
Envío por EUR 2,27Se envía dentro de Estados Unidos de AmericaCantidad disponible: Más de 20 disponibles
Condición: New.
Idioma: Inglés
Editorial: Design Controls, Risk Management and Process Validation for Medical Device Professionals, 2017
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Librería: California Books, Miami, FL, Estados Unidos de AmericaCalifornia Books
Contactar con el vendedorVendedor de 5 estrellasCondición: Nuevo
EUR 153,24
Gastos de envío gratisSe envía dentro de Estados Unidos de AmericaCantidad disponible: Más de 20 disponibles
Condición: New.
Idioma: Inglés
Editorial: Design Controls, Risk Management and Process Validation for Medical Device Professionals, 2017
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Librería: PBShop.store UK, Fairford, GLOS, Reino UnidoPBShop.store UK
Contactar con el vendedorVendedor de 5 estrellasCondición: Nuevo
EUR 147,89
Envío por EUR 7,86Se envía de Reino Unido a Estados Unidos de AmericaCantidad disponible: Más de 20 disponibles
PAP. Condición: New. New Book. Shipped from UK. Established seller since 2000.
Idioma: Inglés
Editorial: Design Controls, Risk Management and Process Validation for Medical Device Professionals, 2017
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Librería: PBShop.store US, Wood Dale, IL, Estados Unidos de AmericaPBShop.store US
Contactar con el vendedorVendedor de 5 estrellasCondición: Nuevo
EUR 156,98
Gastos de envío gratisSe envía dentro de Estados Unidos de AmericaCantidad disponible: Más de 20 disponibles
PAP. Condición: New. New Book. Shipped from UK. Established seller since 2000.
Idioma: Inglés
Editorial: Design Controls, Risk Management and Process Validation for Medical Device Professionals, 2017
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Librería: GreatBookPrices, Columbia, MD, Estados Unidos de AmericaGreatBookPrices
Contactar con el vendedorVendedor de 5 estrellasCondición: Usado - Como Nuevo
EUR 155,36
Envío por EUR 2,27Se envía dentro de Estados Unidos de AmericaCantidad disponible: Más de 20 disponibles
Condición: As New. Unread book in perfect condition.
Idioma: Inglés
Editorial: Design Controls, Risk Management and Process Validation for Medical Device Professionals, 2017
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Librería: GreatBookPricesUK, Woodford Green, Reino UnidoGreatBookPricesUK
Contactar con el vendedorVendedor de 5 estrellasCondición: Nuevo
EUR 147,88
Envío por EUR 17,45Se envía de Reino Unido a Estados Unidos de AmericaCantidad disponible: Más de 20 disponibles
Condición: New.
Idioma: Inglés
Editorial: Design Controls, Risk Management and Process Validation for Medical Device Professionals, 2017
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Librería: GreatBookPricesUK, Woodford Green, Reino UnidoGreatBookPricesUK
Contactar con el vendedorVendedor de 5 estrellasCondición: Usado - Como Nuevo
EUR 161,05
Envío por EUR 17,45Se envía de Reino Unido a Estados Unidos de AmericaCantidad disponible: Más de 20 disponibles
Condición: As New. Unread book in perfect condition.
Idioma: Inglés
Editorial: Design Controls, Risk Management and Process Validation for Medical Device Professionals, 2017
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Librería: Rarewaves.com USA, London, LONDO, Reino UnidoRarewaves.com USA
Contactar con el vendedorVendedor de 5 estrellasCondición: Nuevo
EUR 190,98
Gastos de envío gratisSe envía de Reino Unido a Estados Unidos de AmericaCantidad disponible: Más de 20 disponibles
Paperback. Condición: New.
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Librería: moluna, Greven, Alemaniamoluna
Contactar con el vendedorVendedor de 5 estrellasCondición: Nuevo
EUR 157,84
Envío por EUR 48,99Se envía de Alemania a Estados Unidos de AmericaCantidad disponible: Más de 20 disponibles
Condición: New.
Idioma: Inglés
Editorial: Design Controls, Risk Management and Process Validation for Medical Device Professionals, 2017
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Librería: Rarewaves.com UK, London, Reino UnidoRarewaves.com UK
Contactar con el vendedorVendedor de 5 estrellasCondición: Nuevo
EUR 186,90
Envío por EUR 75,62Se envía de Reino Unido a Estados Unidos de AmericaCantidad disponible: Más de 20 disponibles
Paperback. Condición: New.
Editorial: Amazon Digital Services LLC - KDP Print US
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Librería: AHA-BUCH GmbH, Einbeck, AlemaniaAHA-BUCH GmbH
Contactar con el vendedorVendedor de 5 estrellasCondición: Nuevo
EUR 219,60
Envío por EUR 65,08Se envía de Alemania a Estados Unidos de AmericaCantidad disponible: 2 disponibles
Taschenbuch. Condición: 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 applic…able 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.
Idioma: Inglés
Editorial: Design Controls, Risk Management and Process Validation for Medical Device Professionals, 2017
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- Impresión bajo demanda
Librería: THE SAINT BOOKSTORE, Southport, Reino UnidoTHE SAINT BOOKSTORE
Contactar con el vendedorVendedor de 5 estrellasCondición: Nuevo
EUR 172,38
Envío por EUR 15,40Se envía de Reino Unido a Estados Unidos de AmericaCantidad disponible: Más de 20 disponibles
Paperback / softback. Condición: New. This item is printed on demand. New copy - Usually dispatched within 5-9 working days.
