Medical Device Classification – Australia
Classification Rule 1 – Transient, Short-term, Long-term useThe manufacturer, in determining the classification, must take into account the duration of use:
Classification Rule 2 >>>
How medical devices are regulated in Australia >>>
Australian Medical Device Classification >>>
The Australian Medical Device Essential Principles >>>
|Period of continuous use||Description|
|less than 60 minutes||Transient|
|At least 60 minutes but not more than 30 days||Short term|
|More than 30 days||Long term|
How to implement TQM >>>
Operational Risk Management >>>
Lean Business Model >>>
Cost of Quality >>>
Total Productive Maintenance >>>
Medical Device Validation – Regulation. Requirements & current best Practices.
- How to plan and implement a Validation program.
- How to identify Validation requirements versus actual status.
- The Life Cycle approach to Validation.
- How to identify Validation Gaps and confirm Validation effectivity.
- Reporting on the outcomes of Validations performed.
- Use to develop your personal understanding.
- Use as a support if providing training.
- Details >>>