In this practical presentation, Criterion Edge’s Principal Medical Writer, Dr. Sarah Chavez, presents a detailed outline of the State-of-the-Art search within the Performance Evaluation Report (PER). You will learn how to distinguish between the purpose and scope of the SOA search and the competitor search, in terms of the SLR approach, data screening, and data presentation
The importance of the SOA SLR for providing background and general information
How data will be used to establish acceptance criteria
How to assess the safety and performance of your IVD with a systematic approach to the Competitor SLR process
Who Should Watch?
Those Regulatory, Quality and Clinical leaders and regulatory writers who are tasked with the development, writing, review or approval of Scientific Validity Reports for EU IVDR submission, or anyone interested in learning more about the competitive landscape within the SVR.
Who are the Panelists?
Dr. Sarah Chavez, Principal Medical Writer | Criterion Edge
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