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Important: The Overview of Regulatory Affairs for Medical Device course BIOL-40080 has been updated to BIOL-40322.  To enroll in this course please click on the link below:

Overview of Regulatory Affairs for Medical Device


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: 2.00 unit(s)
Related Certificate Programs: In Vitro Diagnostics