ISO 13485 Training Workshop including LuncheonName: ISO 13485 Training Workshop including LuncheonDate: April 27, 2017Time: 8:00 AM - 1:30 PM MDTRegistration: 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.