Clear outline of the relation between clinical benefit & intended purpose • Overcoming common pitfalls with: – Identifying clinical safety & performance claims – Associated measurable clinical benefits – Defining end-points to support claims & benefits • Surrogate endpoints for GSPR conformity • Lessons from frequent notified body queries • Focus on useful quantity & quality of data
Learning Objectives:
Identifying appropriate and measurable safety and performance objectives
Benchmarking these objectives
Identifying appropriate and sufficient clinical data to support identified claims