March 27, 2019 - March 28, 2019
Date & Time: 27 March 2019 - 8:30 am - 5:00 pm EDT
28 March 2019 - 8:30 am - 4:00 pm EDT
Location: Cincinnati, OH, United States | Cintas Center on the Xavier University Campus
The Looming EU MDR Crisis
Protecting your EU medical device business
Gert Bos, Executive Director & Partner at Qserve Group is invited as global expert leader at the 2-days workshop Xavier MedCon EU MDR Workshop 2019.
New Discoveries and Moving Forward (9:20 AM - 10:20 AM)
This session will help you understand where Europe is moving with its legislation, and why. We will then enhance your understanding with cutting edge interpretation and implementation, from the vantage point of working with many company sizes, many product types, and many unique scenarios. Importantly, we will explore the impact of unclarities such as lack of designated notified bodies, unfinished databases and templates, and the uncertainties around Brexit.
Strategic Product Portfolio Assessment (1:55 PM - 2:55 PM)
This session will focus on the various elements that contribute to the wishes, the possibilities and impossibilities of removing legacies from your portfolio prior to implementing an MDR transition plan. Through case study examples, you will be engaged in exploring the elements of core EU products, legacy sale out, and the effect of market approvals outside of the EU.
Navigating the Gray: Developing Successful Solutions (10:20 AM - 11:50 AM)
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.
Affecting Improvement Across Your Enterprise (12:50 PM - 2:20 PM)
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!
For the full agenda and registration, please visit the official website.
With offices in the USA, Europe, and China we are an essential partner for medical device manufacturers. With our global team of multilingual consultants, Qserve's expertise and experience provide international support, on a local level.