Meet the Authors: Postmarket Requirements for Medical Devices (On-Demand)

1.0 RAC Credits Price: Free
Meet the Authors: Postmarket Requirements for Medical Devices (On-Demand)

This is a December 2022 recording

Come meet the lead authors of RAPS latest e-book, Postmarket Requirements for Medical Devices: A Practical Guide. Hear first hand why the book was developed, who the book was developed for, and how you can benefit from reading it. Get the answers to all your questions on product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market. Find out how you can use this guide to help facilitate the development of global strategies for postmarket regulatory compliance, surveillance, and product changes and how to access and apply relevant postmarket requirement regulations and guidance in specific countries.

Learning Objectives

After completing the virtual class, you will be able to:

  • Recognize who can be held liable under the law
  • Distinguish between fact and opinion
  • Identify who should not be writing opinions on regulatory issues
  • Recognize how Post-it notes can cause trouble for organizations during a lawsuit
  • Identify words that will attract the attention of prosecutors or plaintiffs’ lawyers


Anu Gaur

Anu Gaur
Synergy Global Regulatory Affairs Consultancy, Inc.

Karen Zhou

Karen Zhou
Northeastern University


Contact the RAPS Support Center: 

Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org.

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