The Power of Clinical Data: Why Strategic PMCF Studies Matter, Upcoming Webinar Hosted by Xtalks
Thursday, May 9, 2024
In this webinar, learn about the regulatory framework for post-market clinical follow-up (PMCF). Attendees will gain insights into planning a PMCF strategy and designing a PMCF investigation. The featured speakers will discuss how to conduct a successful PMCF investigation.
TORONTO, May 1, 2024 /PRNewswire-PRWeb/ -- Post-market clinical follow-up (PMCF) studies are necessary for continuously monitoring the clinical benefits, performance and safety of a medical device once it is released on the market. As part of a broader post-market surveillance (PMS) strategy, these studies are crucial for assessing the long-term behavior of the device and ensuring that the risk-benefit profile remains favorable when the device is used as intended.
In addition to satisfying regulatory requirements under the EU Medical Device Regulation (MDR), these studies may even support opportunities to expand both markets and labeling and allow the collection of real-world evidence to inform reimbursement programs.In addition to satisfying regulatory requirements under the EU Medical Device Regulation (MDR), these studies may even support opportunities to expand both markets and labeling and allow the collection of real-world evidence to inform reimbursement programs.
While the specific requirements for PMCF activities may vary based on the type of device, its intended use and the associated risk, clinical investigations are the most robust activity for assessing the ongoing performance and safety of a device. Developing a comprehensive PMCF plan as part of a PMS strategy early in the device lifecycle helps ensure efficient design and implementation of these investigations to maximize study outcomes and address multi-stakeholder requests.
Register for this webinar to explore key regulatory and clinical considerations for PCMF investigations under EU MDR.
Join experts from Premier Research, Frank Keulen, Director, Program Delivery, MedTech; and Caroline Perez, Associate Director, Regulatory Affairs, Medical Devices, Premier Research, for the live webinar on Friday, May 17, 2024, at 10am EDT (4pm CEST/EU-Central).
For more information, or to register for this event, visit The Power of Clinical Data: Why Strategic PMCF Studies Matter.
ABOUT XTALKS
Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars and digital content to the global life science, food, healthcare and medical device communities. Every year, thousands of industry practitioners (from pharmaceutical, biotechnology, food, healthcare and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps professionals stay current with industry developments, regulations and jobs. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.
To learn more about Xtalks visit https://xtalks.com
For information about hosting a webinar visit https://xtalks.com/why-host-a-webinar/
Media Contact
Vera Kovacevic, Xtalks, +1 (416) 977-6555 x371, vkovacevic@xtalks.com, https://xtalks.com
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