The Celegence team can provide complete end-to-end solutions for PMCF; from determining its necessity for a particular device based on the available data to the type of study that is required for PMCF as per the EU MDR. We can also provide a detailed and comprehensive justification if a PMCF is not warranted based on the available clinical data. Our focus is to work with you to develop enhanced proactive systems and implement a strong, risk-based approach. We achieve this by developing and implementing checklists, tools and templates that are easy to understand and use. Our activities center around improvement of manufacturers’ existing PMS systems as well as inputs on whether a PMCF is required. Finally, we can support in designing and facilitating the actual PMCF studies when required. Our team is comprised of subject matter experts who will determine the aim, objectives and set the end points, as well as statisticians to determine the appropriate trial model, the sample size, and interim monitoring. By leveraging Celegence, manufacturers can achieve execution of PMCF activities and the follow-up less time consuming and costly.