We assist our clients in their preparation of the technical file that must be submitted to the TGA. We undertake the risk assessment against the TGA’s requirements and prepare all the reports required to demonstrate that compliance has been achieved for electromedical devices. This includes electrical safety and EMC.
For those clients who want to export their product to the EU we address the requirements as set down in the Medical Devices Directive including protection against:
· Electrical risks
· Mechanical and thermal risks
· EM fields