We are delighted to invite you to our MDR Workshop on Software as a Medical Device on Wednesday, 7 October from 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.
The Workshop will cover the following topics:
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
Shweta Agarwal, MedTech Consultant, Guidehouse
Abtin Rad, Global Director, Functional Safety, TÜV SÜD
To REGISTER for this webinar and to ensure you get all the latest invites and insights by joining our community*, please fill in your details below.
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If you are a lawyer in private practice, please email your MHC contact to register.