Software as a Medical Device: TGA and CSIRO

In the evolving landscape of medical device regulation in Australia, the Therapeutical Goods Administration (TGA) have engaged CSIRO Futures to explore the areas of “Software as a Medical Device” and “Cyber Security for Medical Devices”. They’ve asked people and companies who “identify with this emerging industry” to get involved by making contact via their “Mapping the emerging innovation landscape” project page.

The TGA’s focus is usually on dealing with companies working in these spaces, but I’m curious how many users will get involved.

In this millenium the distinction between software users and creators is less distinct than it used to be, with software being produced by people of all ages and backgrounds. For those of us who build software tools to assist us in managing our own medical conditions, we’re involved in multiple aspects of the industry. And if we then supply these tools for other people we can become suppliers of “medical devices” subject to regulation.

If you feel you have a role to play in these areas, have a look at the CSIRO page linked above. The deadline for registrations is the 20th of August.

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