Recorded lectures

Click a title to view recording

9:00a - 4:30p

April 30

Defining and Classifying Medical Devices
Essential Requirements and Use of Standards

9:00a - 4:30p

May 1

Basic Concepts and Testing of Devices

Packaging, Labeling and Tracking

9:00a - 10:00p

May 2

Conformity Assessment
Competence and Conduct of Regulatory Personnel

9:00a - 4:30p

May 3

Clinical Trials for Medical Devices
Note: Separate registration needed

A detailed agenda from the original can be downloaded here.

Medical Devices ...and More

The medical device industry is one of the most vibrant and important drivers of the health care economies. Regulations to ensure the safety of devices and in vitro diagnostics are evolving rapidly in the international arena. In this course, participants with a basic knowledge of biomedical science and regulatory structures will explore in depth the policies and practices of regulatory research, review, and management for these product classes. At the completion of the course, participants will exhibit a detailed understanding of international standards and practices in relation to local laws, policies, and regulations. They will be able to integrate this knowledge with scientific principles related to the development of experimental protocols and testing paradigms, in order to plan, critique and provide direction to complex device programs.

Registration and Accommodations

Regulators from APEC economies are prioritized as registrants.  Because visa restrictions can be challenging for some participants, we encourage registrants to identify their interest as early as possible, but no later than 4 weeks prior to the program. Financial subsidies can be provided to a limited number of participants from travel-eligible economies to cover costs of up to $1500 per person. Interest in the financial subsidies can be indicated when registering.

Medical Device 101 Registration

Clinical Trial Registration

Travel and Lodging

Financial Support

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