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Software Medical Devices


We will host an MDR Workshop on Software as a Medical Device on Wednesday, 7 October at 5:00pm-6:30pm Irish time. This workshop will involve a panel of speakers representing the perspectives from legal, regulatory consultant and a notified body. 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.

Our webinar will 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.

About the speakerS

Speakers will include:

Michaela Herron, Partner, Mason Hayes & Curran LLP
Richard Poate, Business Development Manager, TÜV SÜD
Alexandros Charitou, Director, Guidehouse
Abtim Rad, Global Director, Functional Safety, TÜV SÜD

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