A cluster of technology developers, focussed on the production of health and medical software including mobile applications, clinical decision support tools and companion apps for medical devices is emerging in Australia. In order to appropriately support this cluster in their knowledge of regulatory requirements, supports and pathways that may relate to medical software innovations CSIRO will engage with industry players to understand their needs.
If you or your company identify with this emerging industry we encourage you to tell us more about your activities and support needs. By taking part in the project you will be invited to contribute to the refinement of cyber security guidelines for the medical device industry.
Update: This project is now complete. Thank you to everyone who provided information regarding the emerging software based devices landscape. We encourage everyone to stay up to date with news from the TGA concerning regulatory activities for software as a medical device. The TGA have recently published an update on the Regulation of Software as a Medical Device.