EU MDR Workshop Agenda:
Day 2



8:00 AM - 8:30 AM


Enjoy a complimentary warm breakfast as we begin the second day of the EU MDR Workshop.

8:30 AM - 10:00 AM

Effective Post-Market Surveillance

Lead Facilitator:

  • Kim Trautman, Executive Vice President, Medical Device International Services, NSF


  • Kristen Hastings, Corp Quality Systems Manager, Global Steward Design Controls, Risk Management and Post Market Surveillance, Boston Scientific

10:00 AM - 10:20 AM


10:20 AM - 11:50 AM

Navigating the Gray: Developing Successful Solutions

This interactive session will enhance your ability to plan for and manage the many uncertainties and unclarities in the EU MDRs. Although the basics are clear, interpretation of the intent and how to meet the intended expectations is far from ready. Join this session to understand how to move forward in this landscape of challenges in a way that you are confident that you have done what you can to be in compliance. With the implementation of tools largely unfinished, we will explore how to successfully address the challenge of hitting a moving target.

Lead Facilitator:

  • Gert Bos, Executive Director & Partner, Qserve Group

11:50 AM - 12:50 PM

Lunch Networking by Topic

Engage in lively discussions with your colleagues and the workshop facilitators at tables dedicated to topics that are important to you as you enjoy your lunch together.

12:50 PM - 2:20 PM

Affecting Improvement Across Your Enterprise

As the workshop comes to a close, there are a lot of learnings you will need to put into action when you return to work so you can affect change in your organization that will protect your patients and your business. Since collaboration is key, how you communicate this information is critical. During this session, you will be engaged in a simulation that will help you put this into action. Build a plan with your peers of what you would communicate to the Board of your company, then get ready for an exciting role playing game!

Lead Facilitators:

  • Gert Bos, Executive Director & Partner, Qserve Group

  • Kim Trautman, Executive Vice President, Medical Device International Services, NSF

2:20 PM - 2:50 PM


2:50 PM - 3:50 PM

Fireside Chat with the Experts

Our panel of expert speakers will take your questions and will do the impossible: help you prepare for the unknown! In a world of uncertainty as it relates to the EU MDRs our expert panel members will take your questions in an informal, collaborative setting that gets to the heart of your most pressing challenges. Don’t miss this opportunity to engage with experts and your industry colleagues in a session to remember.

Lead Facilitator:

  • Philippe Auclair, Pharmacist, Ph.D., Senior Director, Regulatory Strategy and Advocacy, Abbott Quality and Regulatory

3:50 PM - 4:00 PM

To Your Success!

Thank you for joining us, and we look forward to staying engaged with you throughout your journey for the benefit of the patients you serve.

Lead Facilitator:

Marla Phillips, Director, Xavier Health, Xavier University