Description: A CER needs input from several technical files to evaluate clinical safety and performance thoroughly. It can often identify gaps in clinical evidence that can have serious impact on claims and marketing strategy. This presentation highlights how gaps can be handled and what is the minimum information needed for sufficiently designed clinical investigations or other measures. For some manufacturers it can be highly efficient to have common strategies covering several devices.
Learning Objectives:
Streamline information for safety and performance evidence
Be aware of clinical evidence measurements and the resulting impact on clinical claims
Define the need for clinical investigations and other measures and justify their details to combine strategies most efficiently
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