Archives: Agenda

• Planning of a robust study design
• Common hurdles during the start-up phase
• Adhering to timelines for event reporting to regulatory authorities
• Considering financial aspects during the course of a study

• Findings from Greenlight Guru’s 2025 State of Medical Device Industry Report, providing valuable insights into the latest trends, challenges, and innovations in the medical device landscape
• Key industry shifts, including evolving regulatory demands, advancements in clinical technology, and strategies that successful companies are using to navigate complex quality and clinical requirements
• A session for MedTech professionals looking to stay ahead of industry changes and drive forward-thinking quality and clinical practices
• Be among the first ones to access the report before its public release

• Understanding the increasing trend of combining medical devices and drugs
• Gaining insights from the European Medicines Agency (EMA) on the future of medical device and drug combinations
• Explaining the distinction between Medical Devices Regulation (MDR) and Medical Devices Directive (MR) for combination products
• Identifying compliance requirements and implications based on the device’s primary mode of action
• Presenting various regulatory pathways available for combination products
• Understanding how partnerships can drive innovation and development in this domain

This session will explore the pivotal role of clinical technology and AI in driving the success of Medtech trials, focusing on how a unified, AI-enabled platform can serve as the foundation for an expanded data health ecosystem. Attendees will learn the benefits of interconnected data flows, starting with purpose-built, simple electronic data capture (EDC) systems for Medtech trials, scaling by integrating Imaging capabilities, leveraging AI for enhanced data analysis, and enabling seamless one-click imports of Electronic Health Records (EHRs). This approach eliminates redundancies, enhances data integrity, reduces site burden, and can bridge clinical trial data with real-world evidence to improve device observation and long-term insights. By adopting an integrated, AI-driven platform, sponsors can meet current trial demands while building a robust data ecosystem to advance future patient care.

• Recognize the importance of choosing a scalable platform to future-proof clinical trials and enable seamless connections between trial data and real-world evidence for long-term impact
• Understand the role of a unified cloud-based platform in creating a connected data health ecosystem tailored to Medtech trials
• Explore how integrating Imaging and EHR data can enhance operational efficiency, data accuracy, and site engagement

• Navigating the evolving regulatory landscape for AI and software as medical devices
• Integrating AI into existing healthcare systems
• Managing the lifecycle of AI products
• Gaining clinical experience by users of AI based SaMDs

Navigating the journey from preclinical studies to market approval is a critical and complex process for medical devices. This presentation outlines a streamlined approach to ensure regulatory compliance, efficient development, and timely market access

• The importance of correct device classification and its impact on regulatory pathways.
• Strategies to define a comprehensive regulatory roadmap tailored to global requirements.
• Key preclinical tests to establish safety and performance baselines
• Insights into aligning preclinical findings with a robust clinical protocol
• Criteria for selecting the right Notified Body to streamline certification
• Best practices for creating a well-structured technical file to facilitate regulatory review