Wed, 10 Nov

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Software as a Medical Device

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Software as a Medical Device

Time & Location

10 Nov 2021, 12:00 pm – 1:00 pm AEDT

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About the event

This webinar addresses the subject of Software as a Medical Device (SaMD). We have two presenters. 

Jill  Freyne is the Deputy Research Director e-Health at CSIRO Health and Biosecurity. CSIRO has over 100 research scientists working in digital health. Jill led a project to assist the TGA to engage with the Software as a Medical Device industry ahead of the regulatory amendments. In the first part of this presentation, Jill will describe the rationale for SaMD regulation and why greater regulation in this area is a  good thing rather than a hindrance. She will also describe the work going on at CSIRO which is leading digital health advances in Australia.

Olivia Reeves from the Therapeutic Goods Administration will then present a more detailed look a how SaMD is regulated in Australia. This is a follow up on her presentation of 9 Sept where she introduced the topic. She will focus on the intended use of software-only medical devices and how this affects device classification.