Join Notified Bodies and Industry Experts

At this workshop, learn and develop plans to:

JOIN US FOR THE XAVIER EXPERIENCE:

  • Manage concurrent MDD and MDR compliant products, as well as assess the effects of any changes.

  • Ensure market continuity for “Legacy” products after May 2021.

  • Compile the data required for new technical documentation, submissions and mapping to GSPRs.

  • Implement and coordinate post-market data and analysis for proper reporting and trending for mandatory submissions, as well as for compliant QMSs.

  • Heighten awareness of the urgency to take action and gain support from senior leaders (CEO, COO, CQO, CFO, Chief Legal Officer, etc.).

Walk away with practical solutions to successfully prepare your company for the fast-approaching regulation deadline of May 26, 2021.

You Have Questions, and Time is of the Essence!

  • What is the current state of EU MDR?

  • Will you need to spend millions to fulfill clinical data requirements on well-established technologies or legacy devices?

  • What do you need to do if your Notified Body has lost/limited designation?

  • How do you manage the increased cost of hiring, training and development of new resources?

  • What registration and UDI requirements remain in place now that the EUDAMED database launch is delayed to 2022?

  • What are best practices for connecting post market surveillance to design changes and risk management under the new legislation?


How Will This Work?

  • Highly interactive, through the use of virtual breakout rooms, chat box Q&A, and live polling technology.

  • Three concentrated sprints to minimize time away from business matters:

    • Wednesday, June 10, 2020, 9:00am-1:00pm EDT

    • Wednesday, June 17, 2020, 9:00am-1:00pm EDT

    • Thursday, June 18, 9:00am-1:00pm EDT

  • Recordings of each session will be available to you for two weeks after the workshop.

  • You will be emailed your log-in/connection details the week before the workshop starts.


Expert Leaders