Archives: Agenda

• Reducing site burden without weakening interpretability
• Stress-testing endpoints against missingness and real-world workflow
• Preventing avoidable amendments through feasibility discipline

• The importance of starting clinical design data planning very early—even before product design is finalized—to save time, avoid rework, and reduce budget waste
• How early visibility and alignment across product management/marketing, R&D, and clinical/regulatory prevents misalignment and ensures the design supports meaningful evidence generation.
• A practical shift toward design-linked evidence decisions, focusing on the data that will matter later for claims, regulatory expectations, and real-world adoption

• Assessing the impact of the February 2026 transition from QSR to QMSR on submissions and oversight
• Putting knowledge into practice: updating Clinical Study Plans, budgets and regulatory strategies
• Interactive discussion and Q&A

Workshop Overview:
Six months after the transition from QSR to QMSR incorporating ISO 13485, this practical workshop will examine how medical device teams are applying the new requirements in real-world clinical programs. Participants will explore the regulatory elements shaping clinical trial oversight and practice translating QMSR expectations into submissions and Clinical Study Plans, gaining practical insight into navigating both in-flight and future studies within the evolving global regulatory framework.

• Exploring automated data cleaning and reconciliation
• Supporting near real‑time decision‑making
• Strengthening interoperability across clinical systems

Visit our exhibitors’ booths throughout the day and collect stamps in order to enter our Prize Draw and be in for a chance of winning Apple devices or Amazon gift cards. The Prize Draw will take place in the Exhibition Hall, make sure you don’t miss out!