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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 port...
This book provides a comprehensive guide to procuring, utilizing and monetizing intellectual property rights, tailored for readers in the high-tech consumer electronics and software industries, as well as technology startups. Numerous, real examples, case studies and scenarios are incorporated throughout the book to illustrate the topics discussed. Readers will learn what to consider throughout the various creative phases of a product’s lifespan from initial research and development initiatives through post-production. Readers will gain an understanding of the intellectual property protections afforded to U.S. corporations, methods to pro-actively reduce potential problems, and guidelines for future considerations to reduce legal spending, prevent IP theft, and allow for greater profitability from corporate innovation and inventiveness.
This book offers a comprehensive, easy to understand guide for startup entities and developing companies, providing insight on the various sources of funding that are available, how these funding sources are useful at each stage of a company’s development, and offers a comprehensive intellectual property strategy that parallels each stage of development. The IP strategies offered in this book take into consideration the goals that most startups and companies have at each stage of development, as well as the limitations that exist at each stage (i.e., limited available resources earmarked for intellectual property asset development), and provides solutions that startups and companies can im...
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