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We have submitted our product for 60601 certification and all EMC / Safety Markings have come back with passing results. However the test lab is requiring all the risk documentation before they will provide the certification report. Is this common?
For instance, we have not finished our design transfer, but the test house would like to see our risk management report which per our SOP needs to contain process risk evaluation.
For instance, we have not finished our design transfer, but the test house would like to see our risk management report which per our SOP needs to contain process risk evaluation.