Design Controls, Risk Management and Process Validation for Medical Device Professionals

Idioma: inglés

Editorial: Design Controls, Risk Management and Process Validation for Medical Device Professionals, 2017

0692835415 / 9780692835418

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Librería: World of Books Inc, Montgomery, IL, Estados Unidos de AmericaWorld of Books Inc

Vendedor de 4 estrellas

Vendedor de IberLibro desde 23 de marzo de 2026

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Condición: Usado - Regular

EUR 168,91

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Descripción del artículo del vendedor

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 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. …

N° de ref. del artículo CIN0692835415A

Título
Design Controls, Risk Management and Process Validation for Medical Device Professionals
Autor
Vernon M Geckler
Editorial
Design Controls, Risk Management and Process Validation for Medical Device Professionals
Año de publicación
2017
Estado
Fair
Encuadernación
Paperback
Idioma
inglés
ISBN 10
0692835415
ISBN 13
9780692835418

World of Books Inc

Montgomery, IL, Estados Unidos de America

Vendedor de 4 estrellas

Vendedor de IberLibro desde 23 de marzo de 2026

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ArtículoDe 4 a 12 días hábilesDe 3 a 6 días hábiles
Primer artículoEUR 0,00EUR 9,80
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Founded in 2002, World of Books is a leading online destination for buying and selling both preloved and new books, committed to making sustainable reading accessible to all. With a mission to help people read more and waste less, World of Books offers a huge range of affordable, high-quality books — giving both new and preloved titles a second life. The company also operates World of Books – Sell Your Books, an easy-to-use platform that allows customers to trade in unwanted books for cash, helping to keep books in circulation while promoting sustainability. As a Certified B Corp, World of Books is driven by a vision to become the world’s largest and most sustainable dedicated online bookstore. The company measures its success through the positive environmental impact it creates, the value it provides to customers, and its ability to operate profitably while supporting its sustainable mission …

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Información empresarial del vendedor

SBYB, Inc.

900 Knell Road
Montgomery, IL Estados Unidos de America 60538