عنوان

FDA and intellectual property strategies for medical device technologies /

شابک

3030044629

شابک

3030044637

شابک

9783030044626

شابک

9783030044633

شابک اشتباه

3030044610

شابک اشتباه

9783030044619

عنوان اصلي

FDA and intellectual property strategies for medical device technologies /

نام عام مواد

[Book]

نام نخستين پديدآور

Gerald B. Halt, John C. Donch, Amber R. Stiles, Lisa Jenkins VanLuvanee, Brandon R. Theiss and Dana L. Blue.

محل نشرو پخش و غیره

Cham, Switzerland :

نام ناشر، پخش کننده و غيره

Springer,

تاریخ نشرو بخش و غیره

[2019]

نام خاص و کميت اثر

1 online resource (xxiv, 333 pages)

متن يادداشت

Includes bibliographical references and index.

متن يادداشت

General overview of development process -- FDA meetings and device testing -- Compiling and submitting your device application -- During and after review -- Patents -- Trademarks -- Trade secrets -- Copyright in medical device technology -- Design protection for medical devices -- Intellectual property issues in medical device labeling and marketing -- Enforcement, infringement, and monetization of intellectual property rights -- Successful implementation of a medical device company's IP strategy -- Tips for avoiding and preventing intellectual property problems -- Successful implementation of a medical device company's regulatory strategy -- Tips for avoiding and preventing regulatory problems -- Potential combined USPTO and FDA regulatory pitfalls.

بدون عنوان

0

متن يادداشت

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. Investigates the FDA approval process as it pertains to medical device technology Address some of the major FDA hurdles that medical device innovators often face while seeking approval Discusses the interplay between FDA regulatory review of medical device technology and intellectual property strategy Explores the benefits of protecting, managing and enforcing intellectual property obtained for medical device technology so that innovators can obtain the best possible commercial results from their IP ownership Uses real case studies to illustrate concepts covered.

منبع سفارش / آدرس اشتراک

Springer Nature

شماره انبار

com.springer.onix.9783030044626

عنوان

FDA and intellectual property strategies for medical device technologies.

شماره استاندارد بين المللي کتاب و موسيقي

9783030044619

موضوع مستند نشده

United States.

موضوع مستند نشده

United States.

موضوع مستند نشده

Medical instruments and apparatus-- Law and legislation-- United States.

موضوع مستند نشده

Medical technology-- Law and legislation-- United States.

موضوع مستند نشده

Drug and Narcotic Control.

موضوع مستند نشده

Equipment and Supplies.

موضوع مستند نشده

Intellectual Property.

موضوع مستند نشده

Medical Informatics.

موضوع مستند نشده

Drug accessibility.

موضوع مستند نشده

HEALTH & FITNESS-- Holism.

موضوع مستند نشده

HEALTH & FITNESS-- Reference.

موضوع مستند نشده

Intellectual property.

موضوع مستند نشده

International trade.

موضوع مستند نشده

MEDICAL-- Alternative Medicine.

موضوع مستند نشده

MEDICAL-- Atlases.

موضوع مستند نشده

MEDICAL-- Essays.

موضوع مستند نشده

MEDICAL-- Family & General Practice.

موضوع مستند نشده

MEDICAL-- Holistic Medicine.

موضوع مستند نشده

MEDICAL-- Osteopathy.

موضوع مستند نشده

Medical technology.

موضوع مستند نشده

Pharmaceutical policy.

موضوع مستند نشده

HEA-- 012000

موضوع مستند نشده

HEA-- 020000

موضوع مستند نشده

MED-- 004000

موضوع مستند نشده

MED-- 029000

موضوع مستند نشده

MED-- 040000

موضوع مستند نشده

MED-- 092000

موضوع مستند نشده

MED-- 101000

موضوع مستند نشده

MED-- 109000

موضوع مستند نشده

MQW

موضوع مستند نشده

MQW

شماره

ويراست

شماره رده

نشانه اثر

شماره رده

مستند نام اشخاص تاييد نشده

Halt, Gerald B.,Jr.

مستند نام اشخاص تاييد نشده

Blue, Dana L.

مستند نام اشخاص تاييد نشده

Donch, John C.,Jr.

مستند نام اشخاص تاييد نشده

Stiles, Amber R.

مستند نام اشخاص تاييد نشده

Theiss, Brandon R.,1985-

مستند نام اشخاص تاييد نشده

VanLuvanee, Lisa Jenkins

تاريخ عمليات

20200823080557.0

قواعد فهرست نويسي ( بخش توصيفي )

pn

نام الکترونيکي

نوع ماده

[Book]

تكميل شده

Y