In this episode, we're going to talk about Postmarket Surveillance Studies. In light of the EU Medical Device Regulation (MDR), medical device manufacturers are required to implement a Postmarket Surveillance (PMS) plan, which in turn may require them to conduct Postmarket Surveillance Studies. The importance of such studies has grown in recent years as regulators want to know about the safety and effectiveness during the lifetime of a medical device. To learn about Postmarket Surveillance Studies regulatory requirements, process for collecting clinical data for such studies, key elements of PMS plan, and more, I invited Dr. David Rutledge on the podcast. David is the President & CEO at Global Strategic Solutions, where he works as a global consultant for clinical evaluations, clinical risk management, regulatory, quality, and clinical investigations. David brings over 25 years of experience and knowledge in product-level analysis, clinical protocol and case report form development, scientific data analysis, organizational design, integration of science with business needs, quality management systems, signal detection, global clinical evaluations, clinical risk management, and regulatory affairs. David is Six Sigma and CAPA certified, an ISO 13485 lead auditor, and author of Mythical Medical™: Revelations from a Global Product Approval Consultant. * This podcast is brought to you by Florence Healthcare. Florence eliminates chaotic workflows in clinical research operations with remote access and digital workflow platforms. More than 10,000 study sites, sponsors, and CROs in 45 countries trust them to accelerate their operations. To learn more, visit https://florencehc.com This podcast is brought to you by Calyx. Calyx is a trusted name in medical imaging, having delivered imaging services to meet the needs of global biopharmaceutical sponsors and clinical research organizations for over 25 years. To learn more, visit https://www.calyx.ai/ *

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“What did the council decide on item 42?” — answered with the speaker and the moment.

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