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Webinar: Software as a Medical Device

Event Date: 21 April 2021

We will host an MDR Workshop on Software as a Medical Device on Wednesday, 21 April at 4:00pm-6:00pm Irish time. This workshop will involve a panel of speakers looking at the issues from legal, regulatory consultant and notified body perspectives. They will provide practical guidance on how to get software medical devices onto the European market under the upcoming MDR and will provide a deep dive on new obligations arising under the MDR. They will provide practical guidance on how to get software medical devices onto the European market under the upcoming MDR and will provide a deep dive on new obligations arising under the MDR.

The Workshop will cover the following topics:

  • Classification
  • Apps
  • Verification and Validation Testing Requirements
  • Clinical Evidence Requirements
  • Conformity Assessment
  • Post Market Surveillance Obligations
  • Post Market Clinical Follow up
  • The panel will use a practical example of a fictional software medical device to talk interested parties through their obligations and what is expected of them in the fast-approaching new European regulatory framework.

Speakers will include:
James Gallagher, Senior Associate, Mason Hayes & Curran LLP
Richard Poate, Business Development Manager, TÜV SÜD
Alexandros Charitou, Associate Partner, UK & Ireland Life Science Commercial Edge and MedTech lead, EY
Dr Andrei Ninu, Lead Auditor, TÜV SÜD

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