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15 - 17 June 2021
Virtual EventDelivered in CEST time zone
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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
10:15 - 10:205 mins
EU Medical Device Regulation
Opening Remarks
    10:25 - 11:1045 mins
    EU Medical Device Regulation
    First Experiences with EU MDR Submissions
    • Denise Daugert - Principal Regulatory Affairs Specialist, Stryker
    • 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
    • Denise Daugert - Principal Regulatory Affairs Specialist, Stryker
    • 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
    12:30 - 14:0090 mins
    Networking Break Including Economic Operator Roundtable
    • Vanessa Windscheid - Regulatory Affairs & Quality Assurance Director, Nipro Medical Europe
    Session: New Products Chair: Matthias Fink, Global Team Leader Ortho, Trauma and Entistry, Clinical Focus Team Manager, North America, TÜV SÜD America, TÜV SÜD Product Service GmbH
    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
    Artificial Intelligence (AI): Practical Applications to Meet MDR and IVDR Labeling Requirements
    • Kai Simonsen - VP, Production & Quality Systems, Transperfect Medical Device Solutions
    16:05 - 16:5045 mins
    EU Medical Device Regulation
    EUDAMED. How bad can it be?
    • Richard Houlihan - CEO, Eudamed.com
    16:55 - 17:0510 mins
    End of Conference Day 1
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