Course

Post-Market Regulatory Obligations for Medical Devices


Once medical devices are on the market, manufacturers are required to follow specific requirements and regulations. This includes investigating complaints, submitting to the FDA's eMDR system for reporting device malfunctions, injuries or deaths; handling recalls, managing post-market surveillance studies requirements under section 522 of the Federal Food, Drug and Cosmetic Act, as well as post-approval studies required at the time of approval of a premarket approval (PMA); and handling advertising and promotional labeling. This course offers the opportunity to apply these post-market regulatory requirements via in-class activities using case studies.

Prerequisite(s):


Sections Open for Enrollment:

Open Sections and Schedule
Start / End Date Units Location Cost Instructor
09-18-2019 to 12-04-2019 1.5 ONLINE $750

Clarisa A Tate

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Schedule

Date: Start Time: End Time: Meeting Type: Location:
Wed, 09-18-2019 12:00 a.m. 12:00 a.m. Online ONLINE
Wed, 12-04-2019 11:58 p.m. 11:59 p.m. Online ONLINE

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