The necessary requirement of the conformity assessment procedure is the compliance of medical devices is the demonstration of the Clinical Evaluation Report.
There are three options for preparing a clinical assessment report:
conduct a clinical study and summarize the results, or
perform a literary search for clinical research articles or
combination of the first two options.
Preparing clinical evaluations are tedious, but not necessarily challenging. We like to compare the preparation of clinical evaluation reports to bouldering problems. Once someone shows you the most efficient path, climbing the wall no longer seems so challenging.
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