Regulatory Requirements for Medical Devices

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

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.

Click on "See Details" below and refer to "Special Notes" for additional section specific information.