May 23, 2017
In this webinar you will learn about:
Tools for documenting and assessing medical device events
A field action decision-making process that focuses on an assessment of risk and, when appropriate, an assessment of benefit; and
The factors important for the manufacturer to consider to facilitate transparent
communication between the manufacturer and the FDA when there is uncertainty about the adverse public health issues.
The session will also include a brief update on revisions being considered for ISO 14971.