A13. AI/ML in Medical Devices – Demystifying Global Requirements for premarket applications

Tracks
Medical Devices Regulation
Wednesday, June 12, 2024
1:30 PM - 2:30 PM
C3.2

Chair & Speakers

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Ali Hidari
Senior Manager
Cencora PharmaLex

Chair: AI/ML in Medical Devices – Demystifying Global Requirements for premarket applications

Biography

Agenda Item Image
Ali Hidari
Senior Manager
Cencora PharmaLex

AI/ML in Medical Devices – Demystifying Global Requirements for premarket applications

Biography

Ali Hidari is an experienced Medical Devices regulatory professional having held RA and QA roles in a multinational implant manufacturer and his current position as a Senior Manager with Cencora Pharmalex. ​ He is experienced in regulatory pathway, planning and strategy for ANZ markets, preparation of regulatory filings, management of regulatory reviews and postmarket compliance management for a variety of devices, including Software as Medical Devices.​ Ali was awarded a Bachelor of Engineering from University of Exeter in the UK.
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David Hau
Senior Medical Adviser – Devices Clinical Evaluation Section
Medical Devices Authorisations Branch, TGA

AI/ML in Medical Devices – Demystifying Global Requirements for premarket applications

Biography

Dr David Hau joined the Devices Clinical Section of the TGA in 2015. As a senior medical adviser, he currently leads the clinical assessment workstream for conformity assessment applications, and has worked as a clinical assessor in both premarket and postmarket contexts. Dr Hau is a TGA representative currently at the IMDRF AIML and SaMD Working Groups and at the Standards Australia HE-12 Committee on Surgical Implants. Trained in medicine and with BSc and MSc degrees in electrical engineering and computer science from MIT in US, Dr Hau has spent a few years performing hands-on software development at health related startups in Silicon Valley, and has held program director roles in health informatics at the US National Cancer Institute prior to moving to Australia in 2011.
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