Attendees will understand how to strategically evaluate a global reorganization. This includes a change in legal manufacturer and in-country representative. How to perform a strategic assessment of a medical device change globally will also be discussed. Changes which impact human factors and usability per IEC 62366 will also be presented.
Learning Objectives:
Understand important considerations in a change to an organization (merger and acquisition, device sell-off, legal manufacturer, in-country representative).
Recognize the importance of regulatory strategy in assessing the change in a medical device and how to plan for this change globally.
Explain how to perform a regulatory assessment of a global change.
