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Product Identifiers
PublisherElsevier Science & Technology
ISBN-100123919428
ISBN-139780123919427
eBay Product ID (ePID)154357506
Product Key Features
Number of Pages376 Pages
LanguageEnglish
Publication NameMedical Device Design : Innovation from Concept to Market
SubjectIndustrial Engineering, Instruments & Supplies, Biomedical
Publication Year2012
TypeTextbook
AuthorNot Available
Subject AreaTechnology & Engineering, Medical
FormatHardcover
Dimensions
Item Length9.2 in
Item Width7.5 in
Additional Product Features
Intended AudienceCollege Audience
LCCN2012-540007
Dewey Edition23
IllustratedYes
Dewey Decimal610.28/4
Table Of ContentIntroduction Classifying medical devices The design process Implementing design procedures Developing your product design specification Generating ideas and concepts Quality in design Design realization/Detailed design Evaluation (validation and verification) Manufacturing supply chain Labeling and instructions for use Postmarket surveilance Protecting your IP Obtaining regulatory approval to market
SynopsisThis book 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. 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 medical context based on the author's years of academia (R&D phase) and industrial (commercialization phase) experience. This design methodology enables engineers and medical device manufacturers to bring new products to the marketplace rapidly., This book 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. 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 medical context based on the author's years of academia (R&D phase) and industrial (commercialization phase) experience. This design methodology enables engineers and medical device manufacturers to bring new products to the marketplace rapidly. The medical device market is a multi-billion dollar industry. Every engineered product for this sector, from scalpelsstents to complex medical equipment, must be designed and developed to approved procedures and standards. This book shows how Covers US, and EU and ISO standards, enabling a truly international approach, providing a guide to the international standards that practicing engineers require to understand Written by an experienced medical device engineers and entrepreneurs with products in the from the US and UK and with real world experience of developing and commercializing medical products
LC Classification NumberR856
