Postmarket Requirements for Medical Devices: A Practical Guide (e-book)
Table of Contents
Section I: North America: United States and Canada
Chapter 1 Postmarket Compliance and Product Changes: US
Chapter 2 Postmarket Compliance: US
Chapter 3 Postmarket Product Changes: Canada
Chapter 4 Postmarket Compliance: Canada
Chapter 5 Postmarket Surveillance: Canada
Section II: European Union and United Kingdom
Chapter 6 Postmarket Product Changes: EU and UK
Chapter 7 Postmarket Compliance: EU and UK
Chapter 8 Postmarket Surveillance: EU and UK
Section III: Asia-Pacific (APAC)
Chapter 9 Postmarket Product Changes: Japan, China, Australia, New Zealand, and Hong Kong
Chapter 10 Postmarket Compliance: Japan, China, Australia, New Zealand, and Hong Kong
Chapter 11 Postmarket Surveillance: China, Taiwan, and Hong Kong
Chapter 12 Postmarket Surveillance: Japan, South Korea, Australia, and New Zealand
Chapter 13 Postmarket Surveillance: Singapore, Malaysia, and India
Section IV: Latin America (LATAM)
Chapter 14 Postmarket Compliance: Argentina and Chile
Chapter 15 Postmarket Compliance: Brazil, Columbia, Mexico, and Venezuela
Chapter 16 Postmarket Surveillance: Argentina and Chile
Chapter 17 Postmarket Surveillance: Brazil, Colombia, Mexico, and Venezuela
Section V: A Global Perspective on Cybersecurity
Chapter 18 Postmarket Cybersecurity Expectations
Anu Gaur, PhD, MBA, MSRA, RAC-US, RAC-Global and Karen Zhou, JD, MS, RAC-Devices, RAC-Global, editors
About the Book
Available formats: e-book only
Postmarket Requirements for Medical Devices: A Practical Guide is a comprehensive resource covering product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market. This guide can be used to help facilitate the development of global strategies for postmarket regulatory compliance, surveillance, and product changes for regulatory professionals working in the medical device industry.
Global subject matter experts illustrate the mandatory postmarket requirements of medical devices, including lifecycle management including cybersecurity of interconnected devices, and detailed regional regulatory requirements and applications of these requirements globally.
Organized into four major regions, including North America (US, Canada), the European Union (EU) and UK, Asia-Pacific (APAC), and Latin America (LATAM), this book focuses on key global markets with an established regulatory system for medical device premarket and postmarket compliance. Each region highlights critical postmarket regulatory requirements, covering postmarket compliance, postmarket product change types and submissions, and postmarket surveillance. The final section examines global postmarket cybersecurity requirements.
This comprehensive overview of global medical device postmarket requirements will be beneficial for both entry-level and seasoned global regulatory affairs professionals and is intended to be a practical reference guide for both industry and academia.
Who will benefit from this book?
Postmarket Requirements for Medical Devices 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 postmarket requirement 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 postmarket medical device compliance.
This book is a valuable resource for anyone developing a postmarket medical device regulatory strategy.
Purchasing Options
This book can be purchased in the following formats:
- Digital e-book. Single purchase; accessible online via RAPS Library online reader and downloadable.
This book can also be purchased as part of the following bundles:
- All Access Library (12-month digital subscription)
Published by RAPS © 2022. E-book. 352 pages. ISBN (digital): 978-1-947493-83-4.
