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14.00 RAC

Medical Devices Postapproval Bundle

This bundle links three critical regulatory compliance activities following completion of the medical device product realization process—post market surveillance; post-release risk management; and corrections, removals and directed recalls.


Credits:
14.00 RAC

Includes
  • Medical Devices: Postmarket Surveillance
  • Medical Devices: Risk Management
  • Medical Devices: Corrections, Removals and Directed Recalls
  • List Price: $1,650.00
  • Member Price: $1,210.00

 
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Item Details:

This bundle links three critical regulatory compliance activities following completion of the medical device product realization process—post market surveillance; post-release risk management; and corrections, removals and directed recalls. This set of three courses provide an examination of...

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Fundamentals of US Regulatory Affairs, Eighth Edition

Table of Contents

Section I: General Information
Chapter 1 FDA and Related Regulatory Agencies
Chapter 2 History of Food, Drug and Cosmetic Law
Chapter 3 Overview of Drug, Biologic and Device Regulatory Pathways
Chapter 4 FDA Communications and Meetings
Chapter 5 Preparing for Key FDA Meetings and Advisory Committee Meetings
Chapter 6 Crisis Management
Chapter 7 Health Technology Assessment
Chapter 8 Good Laboratory Practice Regulations
Chapter 9 Clinical Trials: GCPs, Regulations and Compliance
Chapter 10 Current Good Manufacturing Practice and Quality System Design