Medical Device Design: Innovation from Concept to Market
暫譯: 醫療器材設計:從概念到上市的創新

Ogrodnik, Peter J.

  • 出版商: Academic Press
  • 出版日期: 2026-09-04
  • 售價: $5,390
  • 貴賓價: 9.5$5,120
  • 語言: 英文
  • 頁數: 624
  • 裝訂: Quality Paper - also called trade paper
  • ISBN: 044340318X
  • ISBN-13: 9780443403187
  • 海外代購書籍(需單獨結帳)

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商品描述

Medical Device Design: Innovation from Concept to Market, Third Edition provides the bridge between engineering design and medical device development. The book clearly explains the process of medical device development - from very early stages of conceptualization to commercialization on the global market. 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, enabling engineers and medical device manufacturers to rapidly bring new products to the marketplace.

This book is suitable for professional engineers, both new and experienced, as well as students taking a course in medical device design.

商品描述(中文翻譯)

《Medical Device Design: Innovation from Concept to Market, Third Edition》搭起工程設計與醫療器材開發之間的橋樑。本書清楚說明醫療器材開發流程——從最初期的概念發想,一直到在全球市場上進行商業化。內容涵蓋醫療器材須符合的法規要求(包括 FDA 與 EU 規範),說明醫療器材設計人員必須了解的重要方法,以確保產品符合相關要求;同時整合經驗驗證的設計流程,協助工程師與醫療器材製造商迅速將新產品推向市場。

本書適合各階段的專業工程師閱讀,無論是初入行或具備豐富經驗者皆然;也適合修習醫療器材設計課程的學生。