EECS X445.2

Regulatory Requirements for Medical Devices

A required course in the Certificate Programs in Medical Device Development, Clinical Trials: Medical Device and Drug Development, and Regulatory Affairs and Compliance.

Increase your understanding of the essential U.S. medical device regulations, including device classification, organizing premarket notification 510(k), and planning and submitting a Pre-market approval (PMA). Gain knowledge on CE mark according to European Medical Device Regulations 2017/745 (EU-MDR), E.U. conformity assessments, meeting E.U. essential requirements, and developing a technical file for the E.U. Get a review of device registrations in Canada, Australia, Japan, China and Latin America. Also, enhance your knowledge of related regulatory topics that include: global vigilance requirements and labeling requirements.

Approximate Cost $735
Format Online
Duration 10 Weeks
Total Credits 3


4/1/2024 - 6/9/2024
Weeks 10
Delivery Online
Fee $735
Status Closed