The goal of performance evaluation is to show that your IVD performs as intended and meets the acceptance criteria, therefore establishing that your IVD may be considered state of the art. Remember: the PER is a product, but it is documenting a process. Performance evaluation can be straightforward if your analyte has a well-established association with a clinical condition. But how should you approach the SVR when there is too much or not enough data?
This webinar will discuss the role of data sufficiency, the importance of developing a solid strategy to establish scientific validity, how gaps in the SVR can significantly impact the quality of the PER, and how proper scoping can help maximize success when it comes to a performance evaluation.
How to clearly define what information should (and shouldn’t) be presented within the Scientific Validity Report.
How the systematic literature review process supports and connects the SVR, CPR, and APR by leveraging published data.
How to conduct gap assessments to assess IVDR readiness and develop strategies to increase efficiencies in the performance evaluation process to support the SVR.
Who are the Panelists?
Sarah J. Chavez, Director, IVD & Scientific Writing Services, Criterion Edge
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