All clinical data sources are considered, as well as some nonclinical trial data that may influence the benefit-risk analysis of the device.

The CE mark is an acronym for "European Conformity", it stands for the French phrase meaning "European Conformity".

A Clinical Evaluation Report (CER) is a medical device safety and assessment report. It is based on clinical data gathered through clinical research.

A medical device consultant works with medical device developers and manufacturers to ensure regulatory compliance and the correction of technical problems or defects in products.