Friday, August 6th, 2010

ADELAIDE (Australia) – In the highly regulated IVD and medical device industry, understanding medical device regulations is essential to successful product launches and on-going sales. IVD and medical device companies that fail to develop a sound regulatory strategy as part of go-to-market plans, risk market entry delays and possible sanction from regulators such as the United States’ FDA and Australian regulator the TGA.

So how can medical device companies gain a clear understanding of the medical device regulations they must meet in each market? One answer is the latest in a series of workshops on Medical Device Regulation, happening this October in Sydney, Melbourne and Adelaide.

Workshop Dates and Registration Details:

Sydney – 13 October, 2010
REGISTER for Sydney Medical Device Regulation workshop:

Melbourne – 15 October, 2010
REGISTER for Melbourne Medical Device Regulation workshop:

Adelaide – 18 October, 2010
REGISTER for Adelaide Medical Device Regulation workshop:

Already more than 200 Australian based medical device professionals have attended the workshop. Commenting on the workshop, one past attendee said, "Great overview. Excellent base from which to start." While another said, "Good clear speakers, very knowledgeable. Interesting examples offered".

Attendees will learn how to develop a regulatory strategy that considers FDA regulations, the European Medical Device Directive (MDD) and TGA regulations in preparation for new medical device export and launch.

Topics include:

  • Identification of product regulatory requirements in target markets
  • Development and prioritisation of product marketing based on sound regulatory strategy
  • Understanding the structure and content of regulatory submissions
  • Management systems required to run the business
  • Management of both pre and post market phases of the device life-cycle 

Presented jointly by regulatory consultants, KD&A, Priory Analysts and MDRA, this workshop is a unique opportunity for Australian medical device companies to gain an understanding of the regulatory requirements for the European and United States markets, as well as for sales in the local Australian market

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KD&A Regulatory Consultants

One of the leading regulatory consultancies in Australia, KD&A provides regulatory solutions for manufacturers of medical devices and in-vitro diagnostics, sponsors and other organisations. Services include: regulatory advice, technical documentation, assistance with quality system certification, quality system maintenance and export assistance.
Philippa Henning
P: +61 (08) 8271 2347
M: +61 (0) 438 821 012


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