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Software as a Medical Device

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Software as a Medical Device
Finding your way through the regulations, state-of-the-art standards, and interpretations applicable to health software, and in particular, software as a medical device (SaMD), can be challenging. Software as a Medical Device, Regulatory and Market Access Implications offers a guide through this complex landscape and provides the expertise of leading software experts.

RAPS new topical book will support readers as they determine whether their software is subject to medical device regulations across the world, how to classify their SaMD, understand the regulatory implications, and develop and optimize their strategy for regulatory submissions and market access. This book will help companies understand their legal obligations and liabilities, providing readers with the necessary tools to plan for the safety, security, usability, and clinical evaluation of their SaMD. It also will help readers identify possible roadblocks and pitfalls to avoid.

Readers will be able to instantly apply the methodology in the book to assess business and product plans, identify possible roadblocks and pitfalls, avoid surprises during software development, regulatory submissions, and software distribution, and convince decision makers to grant your SaMD a place into the care pathways.

Who Should Buy This Book?

Software as a Medical Device was written for regulatory professionals involved in the development or marketing of health software at manufacturers and health institutions worldwide, including regulatory and quality specialists; product, process, project, safety, and security managers; coders and user-experience designers; testers and clinical evaluators. In addition, venture capitalists, incubator hubs, marketers, and health economists will find chapters that focus on their area of interest.

Most of the content requires no prior knowledge of medical device regulations or software development practices and offers insight for beginners as well as seasoned specialists. Additional material provides advanced guidance intended for people that already have a basic understanding of medical device regulations but seek knowledge on how these apply to software, especially SaMD.

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ISBN: 978-1-947493-61-2Published by RAPS © 2021. Paperback. 240 pages.
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