The conduct of a clinical investigation, also referred to as a clinical study in this paper, is one of the most time consuming, and resource intensive activities that a medical device manufacturer can face. For these reasons, manufacturers should ensure that the purpose of the clinical investigation is clear; all applicable regulations, common specifications (e.g. concerning device-specific requirements relevant for clinical investigations), international standards, European guidance documents and any national requirements and guidance documents, have been identified; all persons involved with the study understand their roles and responsibilities; and, the study is well organized and conducted in accordance with relevant QMS practices.
