Clinical evaluation is a process undertaken by the manufacturer with both initial and ongoing/routine actions to substantiate the safety, effectiveness, and performance of their product or device. Methods for assessment must be scientifically based and include:
Collection of initial clinical data and clinical evidence
Adverse event reports
Results from further clinical investigations
Published literature/reports on the device
The end result of this evaluation process is a report proving compliance for regulatory purposes (generally this means substantiating general safety and that the benefits outweigh any “acceptable” risks).