Medical Devices

By: EMCSI PTY LTD (Regulatory Compliance Mark, CE Mark, CE Marking, EMC, RCM Mark, Electrical Safety Approvals, Australian Standards)  01-Sep-2011
Keywords: Ce Marking, Medical Directive

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

· Vibration

· Noise

· Temperature

· EM fields

 

Keywords: Ce Marking, Medical Directive

Contact EMCSI PTY LTD (Regulatory Compliance Mark, CE Mark, CE Marking, EMC, RCM Mark, Electrical Safety Approvals, Australian Standards)

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