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.
Verification and Validation Testing Requirements
Clinical Evidence Requirements
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:
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
Select your location
Bosnia and Herzegovina