The Australian regulations for medical device software, including Software as a Medical Device (SaMD), are undergoing reform. In April 2020 the Therapeutic Goods Administration (TGA) published a consultation paper on the scope of regulated software-based medical devices.
Platypus Technical agrees that there is a need for reform of these regulations, but has concern about some of the proposals in the paper. For the detail of our position, read our response to the consultation in full with the button below.
Dr Lee Walsh the founder and director of Platypus Technical Consultants. Lee is an electrical and biomedical engineer, physiologist, technical consultant and science communicator. He has over a decade of experience in measurement, instrumentation and analysis, particularly in clinical settings, physiology and medical device testing.