EU MDR Workshop Agenda:
Day 2

THURSDAY, MARCH 28, 2019

 

8:00 AM - 8:30 AM

Breakfast

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

During this session, industry experts will engage you in scenario-based discussions that address the challenges of implementing post-market surveillance practices under the expanded requirements of the EU MDR and IVDR regulations. Through group exercises, you will be given a hands-on opportunity to identify how to best support your program and decisions with scientifically sound data, and how to proactively setup data interactions that lead to robust decisions.

Lead Facilitator:

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

Speakers:

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

  • Stephanie Lauman, Global Director, Product Development and Lifecycle Management, bioMérieux


10:00 AM - 10:20 AM

Break


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 - 12:35 PM

Lunch


12:350 PM - 2:05 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


2:05 PM - 2:20 PM

Break


2:20 PM - 3:55 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

Speakers:

  • Bassil Akra, Vice President, TÜV SÜD Product Service

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

  • Gert Bos, Executive Director & Partner, Qserve Group

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

  • Oliver Christ, Executive Vice President, PROSYSTEM, an NSF International Company

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

  • Stephanie Lauman, Global Director, Product Development and Lifecycle Management, bioMérieux


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