Technical Reference Group for Software as a Medical Device (SaMD) and Artificial Intelligence (AI)

A Technical Reference Group for SaMD and AI (TRG for SaMD and AI) has been established to provide expert knowledge to the TGA on complex issues relating to software and AI technologies which may impact medical device regulation.

The TRG for SaMD and AI will allow for access to specialist technical expertise that is required to address increasingly complex technical and regulatory issues emerging from SaMD and AI-enabled medical devices.

The TRG for SaMD and AI acts in a consultative capacity. The Group is not a decision-making or approval body. Meeting outcomes will not be published.

Role of the TRG for SaMD and AI

The TRG will assist the TGA to:

• keep across rapid innovations of new technologies being used in medical devices.
• Identify benefits, risks, barriers and unintended consequences that could result from medical device policies or regulations.
• Identify emerging risks to patients and consumers.
• Identify areas where apps and other software products are crossing the boundary into medical device regulation.
• Understand what education and communication activities are required to support software developers.

Membership

Collectively, members have relevant qualifications, expertise or experience in areas including, AI – generative and other kinds, AI safety, cyber security, cloud platforms, software testing and validation, large scale complex software development, SaMD regulation, digital privacy and software engineering.

Group members

• Associate Professor Stephen Bacchi
• Dr Monica Trujillo
• Dr Sidong Liu
• Mr Paul Clark
• Dr Steve Christov
• Professor Farah Magrabi
• Professor Karin Verspoor
• Professor Peter Leonard

Contact us

Devices Specialist Evaluation Section

Email: TGAMedicalDevices@health.gov.au.