Global Awareness: European Medical Device Regulations

Starting with the fall 2009 term, this course will be renumbered as RGA 6222.

This course covers European Commission directives and guidance documents; European Agency for the Evaluation of Medicinal Products, Medical Device guidance documents, and Notified Body guidelines and recommendations; Global Harmonization Task Force final reports; and mutual recognition agreements. The following topics are covered: biological and biotechnological products, CE marking, conformity assessment and notified bodies, the Global Harmonization Task Force, clinical trials, and standardization.

There are no current sections scheduled for this course number.
Please note that courses have been assigned new numbers beginning with the fall term.
Please check the new course number for course availability.