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.
Speakers:
Michaela Herron, Partner, Mason Hayes & Curran LLP - mherron@mhc.ie
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 events@mhc.ie
