Software as a Medical Device

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Software as a Medical Device

Table of Contents


Lead Editors

Koen Cobbaert, MSc and Gert Bos, MSc, PhD, FRAPS

Product Description

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.

Who should buy this book?

This book was developed for regulatory professionals of all levels of RAPS Regulatory Competency Framework, including newcomers and seasoned professionals as well as academics and governmental employees. Regulatory professionals at Levels 1 and 2 of the framework will be able to easily access relevant regulations and guidance in specific countries and how to apply them in one convenient place. For more senior professionals at Levels 3 and 4 responsible for global regulatory strategy, the book will serve as a valuable resource to facilitate strategic discussions on regulations and policy worldwide.

In a fully and utterly connected world, it is great to see that today medical devices and IVDs are rapidly catching up to match what we have become accustomed to in our daily lives. And slowly, as the device world is getting used to software as a medical device and artificial intelligence, its regulatory hurdle will be dropping. This book shares what the world’s experts have brought together.
Gert Bos, MSc, PhD, FRAPS

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

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