09:00 | Opening |
SESSION FOUR: | Chair - IMDA Regulatory Steering Committee |
09:05 | Unique device identification (UDI) & implications for manufacturers
Jenny Gough, GS1 Specialist Supply Chain Development, Molnlycke |
09:35 | Alternative labelling in Europe & implications for manufacturers
Joachim Wilke, Director of Regulatory Affairs & Policy in Europe, Medtronic |
10:05 | MDDR and implications for diagnostics manufacturers
Jesus Reuda, Regulatory Affairs Director, European Diagnostic Manufacturers Association, EDMA |
10:30 | Q&A |
10:40 - 11:10 | Coffee Break |
SESSION FIVE: | Chair - IMDA Regulatory Steering Committee |
11:15 | Update on current FDA auditing trends & areas of focus
Ann Hunt, Senior Quality Manager, Medtronic Ireland |
11:45 | Capturing Complaints: What to Include and What to Ignore
John Avellanet, Managing Director & Principal at Cerulean Associates LLC |
12:15 | Changing requirements for clinical evidence for medical devices
Niall MacAleenan, Clinical Assessment Manager, Irish Medicines Board |
12:45 | Q&A |
12:55 | Closing Remarks
Sharon Higgins, Director, Irish Medical Devices Association |
13:00 | Lunch |