Archives: Agenda

• Sharing a practical case study on using retrospective clinical data to meet evidence requirements for CE marking
• Demonstrating how to align historical data with current MDR expectations for robust clinical evaluation
• Highlighting lessons learned, common pitfalls, and tips for ensuring Notified Body acceptance

• Future-proof your CERs against class shifts and MDR updates
• Address challenges when intended purpose evolves with technology
• Build defensible clinical arguments for AI-enabled systems

• Understand how notified body reviews differ by organization
• Learn what makes a CER or PMCF study “good enough” in practice
• Avoid overcommitting with evidence plans that are too ambitious

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

• Discussion of approaches to release retrained AI algorithms
• Case study for notified body pre-approval to retrain AI algorithms
• Overview of accompanying clinical evidence requirements
• Impact of AI Act implementation

• ISR Market Research results and insights into the State of AI in Clinical Trials
• Opportunities for companies that embrace AI across the Clinical Trial Lifecycle
• Adoption of AI in MedTech for Clinical Product Development

• Align protocol design with MDR, FDA and global regulatory expectations
• Manage endpoint variability across geographies without undermining quality
• Avoid costly rework by building flexibility into trial strategy

• The reality of PMCF under EU MDR: mandatory, continuous and increasingly scrutinised
• Common pitfalls in current PMCF strategies and why many approaches no longer satisfy Notified Body expectations
• Introducing 1Survey+, a clinical-grade, regulator-ready PMCF platform designed in accordance with ISO 14155
• From fragmented PMCF activities to portfolio-level standardisation and scalability