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Regulatory Affairs for Medical Devices Workshop - Sydney

Speciality Classification
Medical Doctors
Start Date
25-Aug-2022
Location
Sydney, New South Wales 2000
End Date
26-Aug-2022
Delivery
Face to face
Duration
2 days

MTAA has organised a two-day workshop on Regulatory Affairs for Medical Devices Workshop Sydney from 25-26 August 2022. This interactive workshop will provide detailed coverage of the medical device regulations in Australia.

 

The workshop will run as two full-day sessions:

  • Thursday, 25 August from 9:00 to 17:00 AEST
  • Friday, 26 August from 9:00 to 17:00 AEST

 

Location Cliftons Sydney, 60 Margaret Street, Sydney Australia

 

Inclusions

  • Morning tea on both days 
  • Lunch on both days 
  • Afternoon tea on both days 

 

Learning outcomes

  • Basics of Australian Medical Device Regulations and TGA structure and personnel
  • QMS requirements – ISO 13485,  MDSAP
  • Intended use and classification of Medical Devices
  • Market authorisation - EU & FDA
  • Leveraging comparable overseas regulator approvals for TGA applications
  • TGA applications, variation applications, and application audits – Best practice guidelines for a good submission
  • TGA CA applications - Best practice guidelines for a good submission
  • Essential Principles, Risk Management, and Clinical Evidence Requirements
  • Case studies
  • Most recent regulation changes and impacts
  • Q&A with TGA

 

Who should attend? 

  • Regulatory professionals should attend the training. 

     

How much does it cost? 

  • $1,980 Inc. GST for members
  • $2,574 Inc. GST for non-members
Type
Delivery
Title
Regulatory Affairs for Medical Devices Workshop - Sydney
Speciality Classification
Interest Areas / Topics Covered
Technology to assist efficiency of medical professionals
Location
Provider Type
Education Provider
Duration
2 days
Start Date
25-Aug-2022
End Date
26-Aug-2022
Start Time
9:00 am
Price Details
$1980 Inc. GST for members, $2574 Inc. GST for non-members
Location
Sydney, New South Wales 2000
Price:
$1,980.00
$1980 Inc. GST for members, $2574 Inc. GST for non-members
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