Under the MDR, manufacturers are mandated to routinely collect and evaluate data on their high-risk CE-marked devices with PMCF activities. Although these activities can be costly, PMCF processes can be optimized.
With Castor, manufacturers can create and execute PMCF activities smoothly and effectively in just 5 steps. A user-friendly interface guides users to determine PMCF design –by indicating endpoints and whether the data are submitted by a HCP or patients, and whether data are collected prospectively or retrospectively. With this step, forms are automatically generated.
Next, Castor’s interface guides users to define enrollment strategy and then validate the model and forms created. Once PMCF activities have been launched, users can track progress all along, and finally extract the data into charts to be used in reports and submissions.
Read the white paper to learn how Castor’s 5-step approach to PMCF can be used to fulfill MDR requirements.
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