This site is part of the Informa Connect Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 3099067.

Menu
Book
keyboard_arrow_right

Day One - CET/CEST (Cent Europe Summer, GMT+2)

keyboard_arrow_leftSearch & Filter
search

Day One - CET/CEST (Cent Europe Summer, GMT+2)

search
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
      NextDay Two
      Filter
      Streams
      Formats
      Choose Day