Free

Event Information

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Location

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Australia

Event description

Description

The Entrepreneurs' Programme brings together two experts in the field that will be able to assist SMEs to understand from a regulatory and operational perspective what is required to ensure FDA - 510(K) compliance.


This workshop will be valuable to both companies that have this accreditation but also those making the transition and aspire to operate in the medical devices sector.




Presenters

Andrew Batty - Lincoln Consulting Group

Andrew is an experienced MedTech CEO that has developed, executed and managed business strategies to commercialise innovative and emerging technologies. Andrew has experience managing regulatory teams and external consultants to facilitate local and international device distribution.


Arthur Brandwood - Brandwood Biomedical

Brandwood Biomedical is an international medical device and IVD regulatory consultancy, with deep knowledge and experience of US FDA processes including successful traditional and de novo 510(k) submissions and preconsultation interactions with FDA – both remote and face to face. Founder and Principal Consultant Arthur Brandwood has spent more than 30 years in the devices industry. He has worked on biomaterials and device developments in both start up companies and university applied research, has held senior roles including Director of Device Registrations at TGA, represented the industry to government as Chair of the Regulatory expert panel for AusMedtech and for the last 18 years has provided expert consulting services and training to companies and to regulatory agencies across the Asia Pacific.




Locations


Melbourne

Wednesday, 9 May 2018
9:30am - 1:30pm

Deloitte Melbourne
Level 9, 550 Bourke Street
Melbourne VIC 3000


Adelaide

Thursday, 23 August 2018
9:30am - 1:30pm

Deloitte Adelaide
11 Waymouth Street
Adelaide SA 5000


Brisbane

Thursday, 14 March 2018
9:30am - 1:30pm

Deloitte Brisbane
123 Eagle Street
Brisbane QLD 4000


Sydney

Thursday, 4 April 2018
9:30am - 1:30pm

Deloitte Sydney
225 George Street
Sydney NSW 2000



This is a free event hosted by the Department of Industry, Innovation and Science Entrepreneurs' Programme.

This event is designed to benefit small and medium Australian businesses from the Med Tech/Pharma industry sector.

If you have any questions about this event or any future events, please contact EPLearningEvents@industry.gov.au




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