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1.00 RAC

Medical Devices: Definition & Lifecycle

This course is a basic introduction to medical devices, general aspects of product and regulatory lifecycles, including a brief history of medical device regulation and information on basic regulatory principles and concepts as they apply to medical devices.

1.00 RAC

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Medical devices go through a long and complex process of development before being made available for therapeutic or diagnostic use. This process involves professionals from varied backgrounds such as scientists, clinicians, regulatory specialists, legal experts and business specialists.

Whether you...

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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