Please note that all advice and information provided in this webinar is general and applicable to Australia only.
In response to COVID-19 many companies have begun to pivot their activities towards the Medtech industry. Hydrix joined a Life Sciences Queensland hosted webinar to provide medical device innovators with an increased understanding of the manufacturing regulatory process. The webinar focused on Class I non-sterile medical devices, specifically reusable and disposal face masks and filtering face-piece respirators, to help current manufacturers optimise their existing efforts and to assist new manufacturers in their journey.
This session provided an update on the latest industry developments regarding COVID-19 at the time.
Michelle Knight – Hydrix
Michelle is the Clinical and Regulatory Manager at Hydrix Limited and is a qualified Audiologist and Certified Professional with the Association of Clinical Research Professionals. She is an experienced clinical program manager in identifying the scope and requirements of clinical evidence to support global regulatory, marketing and reimbursement needs at Cochlear Limited.
Fiona McCormack and Zoe Barrand – Medical Devices Authorisation Branch, Therapeutic Goods Administration (TGA)
Fiona McCormack is a Principal Technical Advisor and Zoe Barrand is a Senior Medical Device Auditor and MDSAP Assessor, within the Medical Devices Authorisation Branch, Therapeutic Goods Administration (TGA), Australia’s regulatory authority for therapeutic good
Chamindika Konara – Qlicksmart
Chamindika is the General Manager of Qlicksmart, an ISO 13485:2016-accredited R&D and manufacturing company specialising in medical device