株式会社極東書店トップ ＞ 商品一覧 ＞ FDA and Intellectual Property Strategies for Medical Device Technologies. 2019 ed.
商品詳細
FDA and Intellectual Property Strategies for Medical Device Technologies. 2019 ed.
・ISBN 978-3-030-04461-9 hard EUR 149.99
￥40,091.- (税込) ※（※）価格はご注文時の参考価格となります。
納品価格につきましては書籍の入荷時点で確定となります。
版元の原価改定、外国為替の変動等により異なる場合がございますので、予めご了承下さい。
お気に入り
★★★
| 著者・編者 | Halt, Gerald B. / Donch, John C. / Stiles, Amber R. / VanLuvanee, Lisa Jenkins / Theiss, Brandon R. / Blue, Dana L., |
|---|---|
| 出版社 | (Springer Nature Switzerland AG, SZ) |
| 出版年月 | 2019 |
| ページ数 | 333 pp. |
| 言語 | ENG |
| ニュース番号 | ＜A02-98857＞ |
解説
This book offers comprehensive, easy to understand guidance for medical device technology innovators on how to work through the United States FDA regulatory review process, while also providing insight on the various intellectual property concerns that many medical device innovators face. In the first portion of this book, readers are introduced to important concepts concerning FDA compliance for medical devices, as well as strategies for successfully navigating the FDA regulatory review process. Specifically, the first portion discusses the expansive range of medical devices and then walks through the most common routes to market: the PMA and 510(k) application processes. In the second portion of this book, readers are introduced to the various types of intellectual property rights that are available for medical device technology inventions and innovations, and can explore ways to overcome unique intellectual property challenges faced by many medical device technology innovators. In the third portion of the book, specific strategies are discussed to navigate the interface between the FDA regulatory process and the process of obtaining intellectual property protection.
This book also includes a number of descriptive examples, case studies and scenarios to illustrate the topics discussed, and is intended for use by medical device designers, developers and innovators.