The Regulation of Medical Devices
Course 1: The Regulation of Medical Technology
* The following overview may be subject to change.
Registration for this course will be only be offered to those that express an interest to attend a module. Please click on 'Register Your Interest' and include your name and the course you wish to attend. The city and location of the training will be dependent on where the majority of those that have expressed an interest are based.
Click on the course name and/or presenter for more information.
| Module | Duration | Register Your Interest for 2009 | Location | Fee |
1.1 Introduction to the Australian Medical Technology Industry
Presented by the MTAA Secretariat | Evening | Register Your Interest | TBC | $50 Member $75 Non-Member |
1.2 Biohazards and Sterilisation
Presented by Louise White, Tony Rowland and/or Steve Williams, SeerPharma
| Half day | Register Your Interest | TBC | $550 Member $850 Non-Member |
1.3 Introduction to the Regulation of Medical Technology in Australia
Presented by Cliff Spong, MTAA | Half day |
Register Your Interest | TBC | $550 Member $850 Non-Member |
1.4 Advanced Review of the Regulation of Medical Technology in Australia
Presented by Cliff Spong, MTAA | One day | Register Your Interest | TBC | $950 Member $1500 Non-Member |
1.5 Understanding Clinical Evidence for Medical Technology
Presented by Cliff Spong, MTAA | Half day | Register Your Interest | TBC | $550 Member $850 Non-Member |
1.6 Developing Clinical Investigations for Medical Technology
Presented by TBA | One day | Register Your Interest | TBC | $950 Member $1500 Non-Member |
1.7 Quality Management Systems and Conformity Assessment Procedures (QMS & CA)
Presented by Cliff Spong, MTAA, John Jamieson, TGA & Alan Edgecombe | One day | Register Your Interest | TBC | $950 Member $1500 Non-Member |
1.8 The Australian Regulatory System: The DEAL and GMDN Systems
Presented by Cliff Spong, MTAA | Half day |
Register Your Interest
| TBC | $550 Member $850 Non-Member |
1.9 TGA Decisions and Appeals Processes
Presented by Cliff Spong, MTAA | Half day | Register Your Interest | TBC | $550 Member $850 Non-Member |
1.10 Risk Analysis and the Development of Medical Technology
Presented by Steve Williams &/or Paul Kerr, SeerPharma | One day | Register Your Interest | TBC | $950 Member $1500 Non-Member |
1.11 Risk Management for Medical Technology Companies from a Regulatory Perspective
Presented by Steve Williams, Ece Smrdelj &/or Paul Kerr, SeerPharma | One day | Register Your Interest | TBC | $950 Member $1500 Non-Member |
1.12 Developing Technical Documentation for Medical Technology
Presented by Steve Williams &/or Ece Smrdelj, SeerPharma | Half day | Register Your Interest | TBC | $550 Member $850 Non-Member |
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