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Day One - CET/CEST (Cent Europe Summer, GMT+2)
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Day One - CET/CEST (Cent Europe Summer, GMT+2)
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Session: First Experience with the EU MDR Chair: Gert Bos, Executive Director & Partner & Chief Technology Officer, QServe
10:00 - 10:055 mins
EU Medical Device Regulation
Opening Remarks
- Rebecca Brady - Senior Conference Producer, Informa Connect, London
10:10 - 11:1060 mins
EU Medical Device Regulation
First Experiences with EU MDR Submissions
- Regina Short - Program Manager EU MDR, Stryker
- Kemine Hale - Senior Manager Regulatory & Clinical Affairs, Advanced Bionics
- Elizabeth Gfoeller - Corporate Director, Regulatory Affairs, MED-EL, Austria
11:10 - 11:4030 mins
EU Medical Device Regulation
Q+A on First Experiences of EU MDR Submissions
- Regina Short - Program Manager EU MDR, Stryker
- Kemine Hale - Senior Manager Regulatory & Clinical Affairs, Advanced Bionics
- Elizabeth Gfoeller - Corporate Director, Regulatory Affairs, MED-EL, Austria
11:45 - 12:1530 mins
EU Medical Device Regulation
Notified Body Feedback on EU MDR Submissions
- Martin Witte - Global Director, Active Implantable and Cardiovascular Devices, TÜV SÜD
12:15 - 12:2510 mins
EU Medical Device Regulation
Q+A with Notified Body
- Martin Witte - Global Director, Active Implantable and Cardiovascular Devices, TÜV SÜD
12:25 - 13:2560 mins
Networking Break Including Economic Operator Roundtable
- Vanessa Windscheid - Regulatory Affairs & Quality Assurance Director, Nipro Medical Europe
Session: New Products Chair: Bassil Akra, CEO and Co-Owner, QUINQUE
13:25 - 13:5530 mins
EU Medical Device Regulation
Spotlight Session
14:00 - 14:3030 mins
EU Medical Device Regulation
Bringing New Devices to Market Under the EU MDR
- Marianna Luppi, Independent
14:30 - 15:3060 mins
Networking Break including Annex 16 Roundtable
- Melania Battistella - Global Manager of Aesthetic Products, Clinical Reviewer and Clincial Team Lead, TÜV SÜD, Italy
Moderated by Amanda Maxwell, Informa
15:30 - 16:0030 mins
EU Medical Device Regulation
Applying AI to meet EU MDR requirements
- Marc Miller - Division President, TransPerfect Medical Device Solutions
16:05 - 16:5045 mins
EU Medical Device Regulation
First Experiences Using EUDAMED
- Richard Houlihan - CEO, Eudamed.eu
16:55 - 17:2530 mins
EU Medical Device Regulation
Best Practice to Balance MDD and EU MDR Products
- Rose Phan - Independent Consultant, Regulatory Affairs, MDRA Solutions Inc
- Chris MacKay - Independent Consultant, Regulatory Affairs, CJM Medical Device Consulting Ltd
17:25 - 17:3510 mins
End of Conference Day 1
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