Clinical Evaluation and Clinical Investigation

Clinical Evaluation and Clinical Investigation

 

Clinical Investigation is a systematic study performed in humans to access the safety and performance of a medical device based on the comprehensive analysis of available preclinical, Clinical (Safety) and post-market data relevant to the intended purpose of the device.

Clinical evaluation is a process to continuously generate, collect, analyze and assess the clinical data pertaining to a medical device under evaluation to prove the conformity with general safety and performance requirements as per its intended use by manufacturer.

Clinical evaluation is an ongoing process and first conducted during the development stage of medical device throughout its life cycle.

Any one have a better explanation to understand the major differences between Clinical Evaluation and Clinical Investigation?