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Medical Device Design: Innovation from Concept to Market by Peter J. Ogrodnik

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US $187.32
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Last updated on 16 Apr, 2025 18:17:20 BSTView all revisionsView all revisions

Item specifics

Condition
New: A new, unread, unused book in perfect condition with no missing or damaged pages. See the ...
Book Title
Medical Device Design: Innovation from Concept to Market
Publication Date
2019-10-26
Edition Number
2
ISBN
9780128149621

About this product

Product Identifiers

Publisher
Elsevier Science & Technology
ISBN-10
0128149620
ISBN-13
9780128149621
eBay Product ID (ePID)
4038258949

Product Key Features

Number of Pages
532 Pages
Language
English
Publication Name
Medical Device Design : Innovation from Concept to Market
Publication Year
2019
Subject
Instruments & Supplies, Biomedical
Type
Textbook
Author
Peter J. Ogrodnik
Subject Area
Technology & Engineering, Medical
Format
Trade Paperback

Dimensions

Item Length
9.2 in
Item Width
7.5 in

Additional Product Features

Edition Number
2
Intended Audience
Scholarly & Professional
LCCN
2023-301747
Dewey Edition
23
Illustrated
Yes
Dewey Decimal
681.761
Table Of Content
1. Introduction2. Classifying Medical Devices3. The Design Process4. Implementing Design Procedures5. Developing Your Product Design Specification6. Generating Ideas and Concepts7. Enhancing Quality in Design8. Design Realisation/Detailed Design9. Risk Management, Risk Analysis and ISO 1497110. Evaluation (Validation and Verification)11. Manufacturing Supply Chain12. Labelling and Instructions for Use13. Post Market Surveillance14. Protecting Your IP15. Obtaining Regulatory Approval to Market Appendix A. Useful WebsitesAppendix B. TablesAppendix C. ISO 14971 Annex C Pre-Risk Analysis QuestionnaireAppendix D. Generic Codes for Class I Medical Devices (MHRA)Appendix E. Basic Materials Properties for Materials SelectionAppendix F. Standard Materials in Medicak Devices
Synopsis
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, 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.
LC Classification Number
R856

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