Overview of Regulatory Affairs for Medical Device Professionals

Get a comprehensive picture of the medical device regulatory process. The focus will be on FDA laws and regulations required to successfully develop and commercially market medical devices in the United States. Topics include: product development/approval process (IDE, 510(k), PMA), post-market controls, state and federal site inspections, enforcement activities, and suggestions for working proactively with the FDA.

Note: Designed for individuals new to the medical device and biotechnology industries or those considering a career in Regulatory Affairs or Project Management.

Course Number: BIOL-40080   Credit: 2 units

• Course Overview

This course is part of the following Certificate Program(s):

• In Vitro Diagnostics

• Regulatory Affairs Essentials

• Regulatory Affairs for the Biomedical Industry