Internet Explorer 11 (IE11) is not supported. For the best experience please open using Chrome, Firefox, Safari or MS Edge

We hosted an MDR Workshop on Software as a Medical Device on Wednesday, 7 October. This workshop involved a panel of speakers representing the perspectives from legal, regulatory consultant and a notified body. They provided practical guidance on how to get software medical devices onto the European market under the upcoming MDR and also did a deep dive on new obligations arising under the MDR.

The workshop covered 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 used 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.

Michaela Herron, Partner, Mason Hayes & Curran LLP -
Richard Poate, Business Development Manager, TÜV SÜD
Shweta Agarwal, MedTech Consultant, Guidehouse
Abtin Rad, Global Director, Functional Safety, TÜV SÜD

To receive a recording of the webinar, please email

Share this: