In the new episode of our podcast, we delve into the crucial role of statistics in drafting the Post-Market Clinical Follow-Up (PMCF) plan for medical devices.We explore how planning a PMCF study requires an accurate determination of sample size, based on identifying the target population and the prevalence of relevant events.We discuss the importance of data analysis, carried out using advanced statistical software such as R, SAS, or SPSS, and the application of appropriate statistical tests to assess parameters such as clinical effectiveness or user satisfaction.Additionally, we address uncertainty management through statistical tools like confidence intervals and hypothesis testing, which are essential for quantifying the variability of data collected in real-world settings.Finally, we emphasize the importance of clear and transparent communication of results, supported by appropriate visualizations, to ensure proper interpretation of the study’s conclusions.

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