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4.00 RAC

Medical Devices: Postmarket Surveillance

This course highlights the requirements and importance of an effective postmarket surveillance program that satisfies the regulatory and quality system requirements in the US, Canada and Europe.

4.00 RAC

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Regulatory authorities allow medical devices to be placed on the market based on data supporting the reasonable assurance that the proposed device is both safe and effective. These data comprise prospective premarket information generated by using ideal devices under ideal conditions. Retrospective...

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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