Medical Device Design: Innovation from Concept to Market

Price: $150.00 - $9.99
(as of Mar 09, 2026 03:52:34 UTC – Details)


Medical Device Design: Innovation from Concept to Market, Second Edition provides the bridge between engineering design and medical device 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; this book fills that need. It addresses medical devices’ regulatory (FDA and EU) requirements, shows the essential methodologies medical designers must understand to ensure their products meet requirements, and brings together proven design protocols, thus enabling engineers and medical device manufacturers to rapidly bring new products to the marketplace.
This book is unique because it takes the reader through the process of medical device development, from very early stages of conceptualization, to commercialization on the global market. This rare resource can be used by both professionals and newcomers to device design.
– Provides a reference to standards and regulations that have been updated, including ISO 13485:2016, FDA regulations and the European Medical Device Regulation
– Includes new case studies in the areas of classifying medical devices, the design process, quality, labeling, instructions for use, and more
– Presents additional content around software and biocompatibility concerns
ASIN ‏ : ‎ B07ZWZDKV6
Publisher ‏ : ‎ Academic Press
Accessibility ‏ : ‎ Learn more
Publication date ‏ : ‎ October 30, 2019
Edition ‏ : ‎ 2nd
Language ‏ : ‎ English
File size ‏ : ‎ 128.2 MB
Enhanced typesetting ‏ : ‎ Enabled
X-Ray ‏ : ‎ Not Enabled
Word Wise ‏ : ‎ Not Enabled
Print length ‏ : ‎ 514 pages
ISBN-13 ‏ : ‎ 978-0128149638
Page Flip ‏ : ‎ Enabled
Best Sellers Rank: #2,288,558 in Kindle Store (See Top 100 in Kindle Store) #290 in Biomedical Engineering #354 in Biotechnology (Kindle Store) #2,536 in Allied Health Professions (Kindle Store)
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