• ISO 13485 Training Workshop including Luncheon

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    Name: ISO 13485 Training Workshop including Luncheon
    Date: April 27, 2017
    Time: 8:00 AM - 1:30 PM MDT
    Registration: Sorry, public registration for this event has been closed.
    Event Description:

    Check-in & Continental Breakfast  |  7:30am

    ISO 13485 Training Workshop  |  8:00am - 12:00pm

    ISO 13485: 2016 Training will include an overview of the revised standard and an in-depth review of the changes. In this training session, you will also have the opportunity to discuss with other quality and regulatory colleagues the business impact and implementation strategies for the changes.

    Axeon is a firm that specializes in assisting quality-driven organizations to realize their full vision in achieving their quality and profitability objectives.

    Luncheon Presentations  |  12:00pm - 1:30pm
    While Australia boasts a strong market for developing medical technology, the landscape is complex and dynamic when it comes to Regulatory Affairs and Reimbursement. 
    Grant Bennett, Brandwood Biomedical?s CEO, will explore the Australian Regulatory Affairs market; presenting on current trends and emerging issues that may affect organizations operating in the medical device industry.  Grant?s presentation will focus on the Therapeutic Goods Administration (TGA)?s Medical Devices Review (MMDR), changes in the European Union (EU) and an overview of risk classification.
    Additionally, Sarah Griffin, Brandwood Biomedical?s Principal Reimbursement Consultant, will take a look at Australia's medical device reimbursement system. Australia is a desirable and profitable market for medical devices ? with no shortage of applicants, however there are complexities and challenges for the unwary and the process can be lengthy.  Sarah will discuss the latest developments in this market.

    Edwards Lifesciences
    12050 Lone Peak Pkwy
    Draper, UT 84020
    Date/Time Information:
    April 27th
    8:00am - 1:30pm
    Members: $50
    Non-members $65

    Includes a complimentary continental breakfast AND lunch
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