Archives: Agenda

• CO₂ recovery and reuse solutions tailored for breweries
• Improve safety and monitoring with smart control and detection systems
• Reduce CO₂ purchasing, stabilize supply, and lower environmental impact

Senior representative, LogiCo2

• Exemption list and mandatory list
• Regulations for clinical investigation
• Interaction with registration timeline
• Differences in EU and China

• Eclevar delivers ultra-specialized MedTech CRO services in Cardiovascular, Wound, and Orthopaedic areas, easing clinical trials with expert compliance and cost-effective strategies
• Milo empowers tech-enabled solutions like EDC, eCOA, and innovative patient screening identification, reducing complexity and accelerating trial processes for smarter outcomes

• See how to align robust clinical evidence for MDR from an NB perspective
• Bridge the gap between reviewer expectations and sponsor realities
• Optimize clinical trial design and submissions for smoother approval

Chair: Dominic Tong, Senior Analyst, Medical Devices, GlobalData

• Planning modular PMPF studies to generate evidence supporting claim refinement, new use settings, or population expansion
• Addressing gaps from initial submissions and identifying operational challenges
• Leveraging AI tools to streamline post-market data collection, identifying emerging risks earlier, and improving interpretation of real-world performance
• Using PMPF outcomes to support intended purpose expansion and/or claim updates

• Medical device evidence is shifting from one-off trials to continuous, lifecycle-long evidence, with growing emphasis on post-market and real-world data and performance
• Episodic evidence generation models, designed around isolated studies and outsourced delivery, are increasingly misaligned with these expectations and introduce cost, delay and duplication at scale
• How medtech teams can use a single, versatile and affordable platform to run feasibility studies, trials, PMS and RWE in-house, enabling faster evidence generation and systematic reuse across the lifecycle
• A surgical robotics case study showing how clinical trial capabilities are brought in-house and a global clinical registry is leveraged to support evidence generation pre- and post-market

• How an all-in-one eClinical platform simplifies medical device trial operations
• Why API-first interoperability is critical for device studies
• Practical AI use cases that support, rather than replace, clinical teams

• Tracing the evolution of IVDR governance and how MDCG working groups shaped today’s framework and merged responsibilities over recent years
• Exploring behind the scenes of performance study assessments, including what is discussed within the competent authority review process and how applications are evaluated
• Sharing practical recommendations, common pitfalls, lessons learned, and strategies for preparing approval-ready submissions