Software as a Medical Device, Second Edition (e-book)
Table of Contents
Chapter 1: Introduction
Chapter 2: Software as a Medical Device
Chapter 3: Software as an IVD Medical Device
Chapter 4: Classification of Medical Device Software
Chapter 5: Clinical Evaluation of Software
Chapter 6: Safety Risk Management of Software
Chapter 7: Security Risk Management
Chapter 8: Software Development
Chapter 9: Open Source and Third-Party Software
Chapter 10: User Experience Design
Chapter 11: Artificial Intelligence
Chapter 12: Quality and Reliability of Health Apps
Chapter 13: Data Governance and Management
Chapter 14: Digital Supply Chains and Their Regulatory Implications
Chapter 15: Market Access and Reimbursement Pathways for Digital Health Technologies
Chapter 16: Software Liability
Koen Cobbaert, MSc and Gert Bos, MSc, PhD, FRAPS, Lead Editors
About the Book
Available formats: print, e-book, and 3-year digital subscription
Software as a Medical Device, Second Edition is your new guide to one of healthcare’s fastest-evolving frontiers: the intersection of software, regulation, and artificial intelligence. This book aligns the regulatory community with the current state-of-the-art understanding of SaMD, with essential reading on SaMD fundamentals (including for IVDs), software classification, safety and security risk management for software, clinical evaluation of software, and so much more, all written by regulatory experts.
Who will benefit from 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 fast-evolving regulatory landscape, this book serves as a valuable guide for both novices and seasoned regulatory professionals navigating the fast-evolving SaMD and AI segments of the medtech world.
Purchasing Options
This book can be purchased in the following formats:
- Subscription.* A three-year subscription including the digital version listed below as well as automatic updates whenever a new edition and/or chapters are released during the subscription period. Learn more about the subscription.
- Digital e-book. Single purchase; accessible online via RAPS Library online reader and downloadable.
- Printed book.
This book can also be purchased as part of the following bundles:
- All Access Library (12-month digital subscription)
*All subscriptions listed above (excluding the All Access Library) are for three years. They grant you access to the products in the bundle. During this period, you can read the content online or download books as PDFs for offline use. You’ll also receive automatic updates to any new editions of the books and/or chapters included in your subscription. Learn more about subscriptions.
Published by RAPS © 2026. Paperback. 232 pages. ISBN (print): 979-8-9939132-2-3. ISBN (digital): 979-8-9939132-3-0. Library of Congress Control Number: 2026936864.
