Medical Device Regulations Conference 2018

Wednesday, November 7, 2018

8:00-8:15 AM Welcome/Conference Overview Introduction of Speakers David Mullis, Ph.D., RAC, FRAPS University of Georgia 
8:15-9:00 AM FDA ORA Reorganization & Update Blake Bevill, FDA
9:00-9:45 AM Cybersecurity in the Medical Device Industry Seth Carmody, FDA
9:45-10:00 AM Morning Break  
10:00-11:00 AM Insights in FDA Pre-Submission and DeNovo and their Impact on Industry Mark DuVal, JD, DuVal & Associates
11:00 AM-12:30 PM EU MDR Update / Overview Ibim Tariah, PhD, BSI Healthcare
12:30-1:30 PM Networking/Lunch  
1:30-2:15 PM QMS Requirements – ISO 13485:2016 and the EU MDR Lena Cordie, Qualitas
2:15-3:00 PM UDI in the EU MDR – How Different is it from the US FDA UDI? Lena Cordie, Qualitas
3:00-3:15 PM Afternoon Break  
3:15-4:45 PM Changing Clinical Data requirements and Sufficient Clinical Evidence under the EU MDR

Keith Morel, PhD, Qserve

Matthias Fink, MD, TUV SUD

4:45-5:45 PM Panel Discussion Q & A All Speakers

 

Medical Device Regulations Reception 2018

Wednesday, November 7, 2018

6:30 PM-8:00 PM Networking Reception Hampton Inn-Sugarloaf

 

Medical Device Regulations Workshop 2018

Transitioning to the EU MDR – Practical Considerations

Thursday, November 8, 2018

For a detailed description of Transitioning to the EU MDR workshop, click here.

8:00 AM-8:30 AM Welcome/Introductions Melinda Smith/Marybeth Henderson
8:30 AM-11:30 AM Sufficient Clinical Evidence Case Studies  

Primary Presenters:
Matthias Fink, M.D.
TUV SUD

Keith Morel, Ph.D.
Qserve

 

 

Supporting Team:
Mary Beth Henderson
RCRI

 

 

Lena Cordie
Qualitas

 

 

Ibim Tariah
BSI Healthcare

 
 

Melinda Smith
NeoMed, Inc.

 

Caitlin Senter
Remington Medical

10:00 AM-10:15 AM Break
10:15 AM-11:30 AM Sufficient Clinical Evidence Case Studies (con’t)
11:30 AM-12:00 PM Article 120 and the Soft Transition to the MDR
12:00 PM-1:00 PM Lunch
1:00 PM-2:30 PM Structuring your MDR Project and Practical Issues
2:30 PM-3:00 PM EU MDR Labeling Requirements & Changes
3:00 PM-3:15 PM Break
3:15 PM-4:30 PM Supply Chain/Economic Operation Considerations
4:30 PM-5:00 PM Hazardous Materials Considerations