Global Medical Device Regulatory Strategy, Third Edition
Table of Contents
Chapter 1: Driving Successful Commercial Product Launches
Chapter 2: Development and Implementation of Regulatory Strategies for Medical Devices
Chapter 3: Core Development Teams
Chapter 4: Components of Regulatory Strategy—The Basics
Chapter 5: Setting up a Quality Management System
Chapter 6: Risk Management Strategies for Device Design and Development Processes
Chapter 7: Global Medical Device Labeling Strategies
Chapter 8: Manufacturing
Chapter 9: Nonclinical Laboratory Testing
Chapter 10: Global Medical Device Clinical Strategy
Chapter 11: In Vitro Diagnostic Medical Devices
Chapter 12: Combination Products
Chapter 13: Global Regulatory Processes
Chapter 14: Global Regulatory Process—Third-Party Point of View
Chapter 15: Use of Standards in Medical Device Global Regulatory Strategy
Chapter 16: Global Medical Device Marketing Strategy
Chapter 17: Regulatory Resources for Strategy Development
Chapter 18: Global Postmarketing Regulatory Strategy
Chapter 19: Borderline Regulation of Stem Cell Technologies: Therapies, Devices and Combination Products
Chapter 20: Patents and Intellectual Property
Chapter 21: Software
Chapter 22: Cybersecurity
Peter A. Takes, PhD, RAC, FRAPS, and Susumu Nozawa, RAC, FRAPS, editors
About the Book
Available formats: print, e-book, and 3-year digital subscription
Global Medical Device Regulatory Strategy, Third Edition is the go-to resource to guide you in creating, implementing, and maintaining an effective medical device regulatory strategy. The authors tactically respond to market analysis, identifying business opportunities and developing strategies to drive successful product launches.
Addressing rapid technological advancements, this book will help you anticipate concurrent shifts in regulations and requirements governing medical devices. It highlights the major regulatory changes to medical devices in both the EU and the US, among others. Learn from regulatory strategy experts on how to enhance the impact of medical device development on economic, clinical, healthcare, marketing, and corporate strategy.
Please note that print book orders may currently be delayed while we restock. We appreciate your patience!
Who will benefit from this book?
This book is intended for both the experienced regulatory professional and those entering the profession and designing their own pathway to success in this vastly enriching field. It can be used as a contemporary and integral bookshelf reference in Regulatory Affairs departments of all sizes, as well as a routine textbook in expanding academic curricula in regulatory affairs and quality systems.
This book addresses current prevalent changes, including a multiplicity of new challenges which require continual monitoring by appropriately qualified regulatory professionals. It outlines and explains the core information and newest developments essential to such a monumental task.
Purchasing Options
This book can be purchased in the following formats:
- Subscription.* A three-year subscription including the digital version listed above 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)
- Regulatory Excellence Bundle: Medical Devices (subscription).* Includes the digital e-book subscription to:
- Fundamentals of Medical Device Regulations: A Global Perspective
- Global Medical Device Regulatory Strategy, Third Edition
- Regulatory Intelligence Reimagined
*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. 332 pages. ISBN (print): 979-8-9939132-4-7. ISBN (digital): 979-8-9939132-5-4. Library of Congress Control Number: 2026941208.
