Australian TGA Presentation on Software Regulation

In August 2014, the Australian Therapeutic Goods Authority (TGA) gave a presentation on its approach to software regulation of medical devices.  This is a short and very clear high level presentation that explains the TGA’s focus and use of relevant standards such as 62304 as well as its focus on safety and risk management.

View the presentation at this link:  TGA Regulation of medical software and MMApps

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