RAS627

Download as PDF

Intl Regulatory Affairs: European Union, East Europe, Australia & Canada

Applied Education in MedTech Industry Graduate College of Science and Engineering

Prefix

RAS

Course Number

627

Course ID

00137412-2023-03-15

Course Level

Graduate

College/School

College of Science and Engineering

Description

International regulatory affairs for medical devices with emphasis on the European Union (EU), Eastern Europe, Australia and Canada Regulatory requirements. Classification, marketing submissions, and pre- and post-market approval requirements. Regulatory strategies for global market introduction and planning for the challenges of global regulation.