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2.00 RAC

Intermediate Medical Writing: Medical Devices

This course provides an overview of some of the more complex documents prepared by regulatory and medical writers, including key sections of the Premarket Approval (PMA) and 510(k) Premarket Notification applications.


Credits:
2.00 RAC

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Regulatory writing is an integral part of the product development and approval process and plays a crucial role in speeding product submission and supporting compliance.

This course will provide an overview of some of the more complex documents prepared by regulatory and medical writers, including...

Back to Intermediate Medical Writing: Medical Devices
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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