Regulatory Requirements for Medical Devices

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.