Postmarket Requirements for Medical Devices: A Practical Guide (e-book)

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Postmarket Requirements for Medical Devices: A Practical Guide (e-book)

Table of Contents


Lead Editors

Anu Gaur, PhD, MBA, MSRA, RAC-US, RAC-Global and Karen Zhou, JD, MS, RAC-Devices, RAC-Global

Product Description

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.

Who should buy 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.​
Karen Zhou, JD, MS, RAC-Devices, RAC-Global

Published by RAPS © 2022. E-book. 352 pages. ISBN: 978-1-947493-83-4.

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