Medical Device Classification – Australia

Classification Rule 1 – Transient, Short-term, Long-term use

The 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 useDescription
less than 60 minutesTransient
At least 60 minutes but not more than 30 daysShort term
More than 30 daysLong term
Benchmarking >>>
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 >>>