Medical Device Complaints, MDRs & Reports Workshop
April 16 - 17, 2019 | Washington, DC
Are you prepared to implement and measure the effectiveness of a complaint handling system covering a diverse set of possible products and problems? How are complaint files managed across multiple domestic and international facilities? When do complaints rise to the level of MDR's, and how do you handle recalls? What are the current FDA enforcement trends in these areas? Industry experts and FDA staff will explore these issues during this day and a half workshop.
Learn more and register here
Recalls From A To Z: Regulations, Decisions, Procedures, And Best Practices Workshop
April 17 - 18, 2019 | Washington, DC
During this workshop you'll establish a clear understanding how the regulatory affairs function is pivotal to every recall and every team decision. After partaking in detailed discussions and strategies of communicating with the FDA, you'll learn to understand the points to consider when writing public recall notifications. At this interactive workshop, you will have access to network with industry leaders and FDA experts.
510(k) Submissions Workshop
May 13 - 14, 2019 | Irvine, CA
This two day workshop provides attendees the unique opportunity to better understand the FDA perspective on 510(k) submissions, from processes to approval to modifications. Throughout the workshop you'll obtain actionable insights and strategies for assembling and streamlining an effective 510(k) submission.
IDE Submissions Workshop
May 15, 2019 | Irvine, CA
This unique opportunity will help you better understand the FDA perspective on IDE submissions, from processes to approval to
modifications. Throughout the 1-day workshop, you’ll obtain actionable insights and strategies for assembling and streamlining an effective IDE submission.
PMA Submissions Workshop
May 16 - 17, 2019 | Irvine, CA
Completing the set of interactive submissions workshops, industry and FDA experts will lead you through the strategic considerations and practical steps of filing a Premarket Approval.
Interested in learning more about other AdvaMed Events in 2019?
For questions, please email us at AdvaMedEvents@AdvaMed.org.