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Search results with tag "Adverse event reporting guidance"
GHTF SG2 Guidance for Adverse Event Reporting for …
www.imdrf.orgThis document is a consolidation of final GHTF guidance on Adverse Event Reporting. It was produced by combining GHTF/SG2/N21 Adverse Event Reporting Guidance for the Medical Device Manufacturer or its Authorized Representative with the requirements from the following documents: