Name: Fda and Intellectual Property Strategies for Medical Device Technologies: Including Artificial Intelligence, Software and Applications (en Inglés)
Price: 423487.00 COP
Availability: InStock
Author: Gerald B. Halt Jr.; John C. Donch Jr.; Amber R. Stiles; Brandon R. Theiss; Michelle Byrne; William F. Hodnick; Joshua Eldridge; Randy Goodman; Lisa Jenkins Vanluvanee; Dana L. Blue
ISBN: 9783032126481

portada Fda and Intellectual Property Strategies for Medical Device Technologies: Including Artificial Intelligence, Software and Applications (en Inglés)

Fda and Intellectual Property Strategies for Medical Device Technologies: Including Artificial Intelligence, Software and Applications (en Inglés)

Formato

Libro Físico

Editorial

Springer

Autor

Gerald B. Halt Jr.; John C. Donch Jr.; Amber R. Stiles; Brandon R. Theiss; Michelle Byrne; William F. Hodnick; Joshua Eldridge; Randy Goodman; Lisa Jenkins Vanluvanee; Dana L. Blue

Idioma

Inglés

N° páginas

433

Encuadernación

Tapa Dura

ISBN13

9783032126481

N° edición

0002

Fda and Intellectual Property Strategies for Medical Device Technologies: Including Artificial Intelligence, Software and Applications (en Inglés)

Gerald B. Halt Jr.; John C. Donch Jr.; Amber R. Stiles; Brandon R. Theiss; Michelle Byrne; William F. Hodnick; Joshua Eldridge; Randy Goodman; Lisa Jenkins Vanluvanee; Dana L. Blue (Autor) · Springer · Tapa Dura

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Reseña del libro "Fda and Intellectual Property Strategies for Medical Device Technologies: Including Artificial Intelligence, Software and Applications (en Inglés)"

This book offers comprehensive, easy to understand guidance for medical device technology innovators on how to work through the United States Food and Drug Administration (US FDA) regulatory review and approval/grant/clearance 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 and approval/grant/clearance process. Specifically, the first portion discusses the expansive range of medical devices and then walks through the most common routes to market: the PMA, 510(k), and De Novo application processes. The complexities of medical device commercialization in the US market are also discussed. Additionally, this book explores how Artificial Intelligence (AI) and new software innovations are impacting the medical regulatory space. 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.