Medical device safety is rarely defined by a single document or activity. Rather, it emerges from the consistency and alignment of risk management, clinical evaluation, and real-world feedback throughout the product lifecycle. 

This session explores the concept of "One Safety Story": how different safety-related activities and sources of evidence should work together to support a coherent benefit-risk assessment. Through practical observations and examples, the presentation will discuss common gaps in alignment, why they matter, and how stronger integration can improve both product safety and overall regulatory confidence.