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Medical Device Design Innovation from Concept to Market

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ISBN-10: 0123919428

ISBN-13: 9780123919427

Edition: 2013

Authors: Peter Ogrodnik

List price: $92.50
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This book provides the bridge between engineering design and medical devices development. There is no single text that addresses the plethora of design issues a medical devices designer meets when developing new products or improving older ones. It addresses medical devices regulatory (FDA and EU) requirements: some of the most stringent engineering requirements globally. Engineers failing to meet these requirements can cause serious harm to users as well as their products' commercial prospects. This Handbook shows the essential methodologies medical designers must understand to ensure their products meet requirements. It brings together proven design protocols and puts them in an explicit…    
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Book details

List price: $92.50
Copyright year: 2013
Publisher: Elsevier Science & Technology
Publication date: 11/26/2012
Binding: Hardcover
Pages: 376
Size: 8.00" wide x 9.50" long x 1.50" tall
Weight: 1.848
Language: English

Medical devices: Definitions by FDA, MDD
The design process
Product development procedures
Developing a design specification
Ideas generation and selection
Implementing Quality in Design
FMEA Risk analysis 2k factorials
House of quality design optimization
Design for manufacture
Design for assembly
Design for disassembly
Life cycle analysis and environmental regulation