Do you have questions about how to generate, collect, analyze, or assess clinical data pertaining to your IVD? What are the best practices for conducting literature searches? How do you effectively present your data in your performance evaluation report? Whether you are just beginning your PER preparations or are already in the process of writing, we will provide insights and suggestions to help make the process of data collection, extraction, and presentation more streamlined.
This forum answers question like these and more. Click here to watch the recording.
The implementation of IVDR requirements has challenged IVD manufacturers to align their internal processes and systems with these rigorous regulations. Therefore, companies realize reviewing published literature for device-specific clinical data to establish the state-of-the-art (scientific validity) is imperative. In addition, establishing clinical performance of their products is key. However, many manufacturers may not be familiar with or have the capability to perform rigorous, IVDR-compliant systematic literature reviews (SLR). Finally, screening, selection and data extraction are typically challenges for manufacturers as well.
In this presentation we break down the steps of the SLR process and take a wholistic approach to conducting an IVDR-compliant SLR. Next, using case studies, we illustrate the effective use of SLR-derived data to develop the Scientific Validity Report (SVR) and the Clinical Performance Report (CPR).
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