The MDR is forcing many MedTech companies to conduct clinical studies to gather data for Post-Market Clinical Follow-Up (PMCF) and clinical evaluation.
One of the first crucial steps in designing a clinical study is determining the number of subjects to recruit i.e the study sample size.
To pass scrutiny from Notified Bodies on PMCF and clinical investigation plans, you have to justify sample size estimation with scientific reasoning.
In this webinar you will learn:
- The basic inputs behind sample size estimation
- How study design can impact sample size
- How to prepare for a discussion on sample size with a statistician
Keywords: Medical Device, Clinical Study, Sample Size
Jón I. Bergsteinsson
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