We were very excited to host a presentation by Tracey Duffy, First Assistant Secretary of the Medical Devices & Product Quality Division at the Therapeutic Goods Administration.

Ms Duffy leads the Medical Devices and Product Quality Division at the TGA. Her team is responsible for the regulation of software (artificial intelligence) intended for therapeutic purposes and her presentation was titled:

Regulatory Requirements for Software, AI, and Medical Devices

Ms. Duffy provided insights into:

– Current regulatory requirements for AI and software in therapeutic applications.
– Implementation updates and lessons learned from changes introduced in early 2021.

Key takeaways from the whole-of-economy AI Review and its impact on the industry.

As a leader at the TGA, Ms. Duffy’s expertise helped to shed light on how cutting-edge technologies are being regulated to ensure safety and efficacy in healthcare.

Please click here to watch the presentation or click here to view the slides