Clinical Trials in Medical Devices

This session focuses on the unique aspects of conducting clinical trials for medical devices, including regulatory pathways, trial design, and post-market surveillance. Topics include device classification, risk assessment, and regulatory approval processes across different regions. Subtopics cover clinical evaluation plans, safety and performance endpoints, and patient monitoring requirements specific to devices. Attendees will learn strategies for designing trials that demonstrate efficacy while minimizing patient risk, as well as the use of real-world evidence and registries for post-market data collection. Case studies of successful device trials will highlight challenges in recruitment, protocol compliance, and data collection. The session will also address emerging trends, such as digital health devices, wearable technologies, and combination products, emphasizing the integration of technological innovation with regulatory compliance. By the end of this session, participants will gain practical knowledge to plan, execute, and monitor medical device trials effectively, ensuring successful product approvals and patient safety.

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