Description: Clinical evaluation accounts for nearly half of all non-conformities issued by notified bodies. There is a plethora of aspects to a properly documented clinical evaluation, including identification of benefits and indications, literature searches, statistical analysis of data found, and supplying evidence. This lesson will focus on a system wide failure mode frequently seen, which touches all these items: State of the art searches. This training will cover the expectation values of the notified bodies on literature searches and how to set yourself up to succeed in everything it touches.
Learning Objectives:
You will be able to know when a search is sufficiently broad to have identified all relevant data
You will be able to determine if the performance and safety objectives you have derived are sufficiently specific and measurable
You will be able to know if you have identified enough clinical data from literature to meet your objectives
