Overcoming Regulatory Hurdles for Devices

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This Entrepreneurs' Programme Learning Event brings together two experts in the field that will be able to assist SMEs to understand, for a regulatory and operational perspective, what is required to ensure ISO13485 compliance.

This event will be valuable to both companies that have this accreditation but also to those making transitions and aspire to operate in the medical device sector.

Andrew Batty, Lincoln Consolting

Andrew is an experienced MedTech CEO that has developed, executed and managed business strategies to commercialise innovative and emerging technologies. Andrew has worked in Sales, Marketing, Business Development, Clinical Operations and Management with pharmaceutical (Roche & GSK) and biotechnology companies. Andrew has raised private capital and has worked to commercialise 4 private and ASX listed medtech startup companies (CogState, Panvax, IM Medical and Anatomics). Andrew has secured ISO13485 certification for manufactured devices and recruited distributors for overseas markets, executing supplier and distribution agreements with Pfizer, Stryker, Medtronic and BBraun Aesculap.

Seamus Orr, PharmOut

Seamus is the NSW Manager for PharmOut. PharmOut is a rapidly growing international consultancy offering GMP compliance, qualification & validation, TGA regulatory, engineering and architectural consulting services to the pharmaceutical, blood & tissue, pesticides and veterinary and medical device manufacturers, as well as related hospital and pharmacy operations.



Thursday, 7 December 2017

12:30pm - 4:00pm (local time)

Deloitte Office

550 Bourke Street

Melbourne VIC 3000

TBC Queensland

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


This event is designed to benefit small and medium Australian businesses from the Medical Technolgy and Pharmaceutical industry sector.

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