Software as a Medical Device (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 Components
Chapter 10: Software Usability Engineering
Chapter 11: Artificial Intelligence
Chapter 12: Quality and Reliability of Health Apps
Chapter 13: Regulatory Implications of Digital Distribution Models for Medical Device Software
Chapter 14: Market Access and Reimbursement for Digital Health Technologies
Chapter 15: Software Liability
Koen Cobbaert, MSc and Gert Bos, MSc, PhD, FRAPS, editors
About the Book
Available formats: print, e-book, and 3-year digital subscription
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 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.
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 © 2021. Paperback. 240 pages. ISBN (print): 978-1-947493-61-2. ISBN (digital): 978-1-947493-62-9.
