Webinar: Improving the Postmarket Surveillance Process

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.

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