Introduction to medical device regulation
Date and time
Location
Online event
Webinar on "Introduction to medical device regulation"
About this event
In this webinar from the ARC Training Centre for Medical Implant Technologies (CMIT), Dr Jia-Yee Lee will present an "Introduction to medical device regulation".
The webinar is for PhD students and researchers with limited understanding of the regulatory requirements for medical device development.
CMIT extends this invitation to PhD students and researchers at
- ARC Training Centre for Personalised Therapeutics Technologies;
- ARC Training Centre in Cognitive Computing for Medical Technologies;
- ARC Training Centre for Innovative BioEngineering;
- ARC Training Centre for Joint Biomechanic.
The webinar will provide an overview of the regulatory requirements of medical devices. Case studies that includes an active implantable medical device will be provided.
Expected learning outcomes:
- An understanding of the global regulatory landscape with specific reference to Australia, US and EU regulatory requirements;
- International standards relevant to medical devices;
- The importance of a regulatory strategy within a commercialisation strategy.
Note: A Zoom link will be emailed to attendees who have registered for the event.
Profile
Dr Jia-Yee Lee is the Enterprise Fellow at Melbourne School of Engineering, University of Melbourne with responsibilities in industry engagement. She is also the Co-Manager of the ARC Training Centre for Medical Implant Technologies (ARC CMIT). Prior to this role, Jia-Yee was Director of Industry Engagement at the Graeme Clark Institute for Biomedical Engineering at the University of Melbourne.Jia-Yee has experiences in technology startup and commercialisation, and in developing government policies in health and medical research. Jia-Yee is a mentor at CivVic Labs, a Victorian Government accelerator program under LaunchVic. She was formerly Director, Health and Life Sciences at National ICT Australia (NICTA, now Data61) where she led engineers, computer scientists and mathematicians to drive innovation in Diagnostic Genomics, Assistive Technologies and Biomedical Informatics. Jia-Yee has spent more than twenty years in medical research having led NHMRC funded projects at the Victorian Infectious Diseases Reference Laboratory (now at Doherty Institute) and the Macfarlane Burnet Centre (now Burnet Institute). She has a PhD (Virology) and MBA (Melbourne Business School) from University of Melbourne.
