Date: 3 May 2018
Location: Cincinnati, OH, United States | Cintas Center on the Xavier University Campus
Gert Bos, Executive Director and Partner at Qserve Group is invited as speaker at the FDA/Xavier MedCon.
8:40 AM - 9:40 AM - EU Regulations: Beyond the Unknown
The European Regulations for Medical Devices and In Vitro Diagnostic Devices have been published for more than a year. Now that there are fewer unknowns, we can dive deep into understanding the “how to” and the impact of these regulations. During this session participants will understand the implementation progress related to NB designation, Governance of the MDR/IVDR (MDCG), defining the “Implementing and Delegated” acts and the EUDAMED database. Participants will also walk away with insight on what is known about the impact of Brexit on medical technologies. Don’t miss this opportunity to ensure your organization is aligned with your colleagues across the industry.
1:35 PM - 2:40 PM - International Track
China - Land of Opportunity and Challenges: Perhaps the most dynamic market in the world, China's rapidly expanding economy and continuously evolving regulatory landscape represents opportunities and challenges to medical device innovators. This session will provide an overview of the evolving regulatory landscape in China and present case studies on successful practices.
4:00 PM - 5:00 PM - How Medical Device Firms are Gearing Up for Compliance with Europe’s New Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR)
The session will poll the attendees and members of the industry on the progress they have made to meet the requirements of the new European MDR and IVDR. Following a discussion of the poll results, representatives from medical device and IVD companies will provide examples of ways they are addressing the requirements.
Please check the full program here and we hope to see you there!
MedCon brings the global Medical Device community together to openly discuss the most pressing issues facing our industry. You have the opportunity to influence decisions and have your voice heard as you interact with leading FDA officials and field investigators, along with global industry experts.