PMCF in 5 steps Authors: D.L. Arts & F.T. Colonna WHITEPAPER JANUARY 2020 How Castor EDC can help you achieve MDR compliance (Part II) This document provides a brief overview of how Castor’s 5-step approach to PMCF can be used to fulfill MDR requirements.castoredc.com 2 Content Executive Summary Background The PMCF challenge PMCF in 5 steps STEP 1: Decide on your approach STEP 2: Define your enrollment strategy STEP 3: Validate Model STEP 4: Track progress STEP 5: Extract PMCF data About Castor Get in touch References Page 3 4 5 6 7 10 11 12 13 14 15 15 castoredc.com 3 Executive Summary 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,

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