In the dynamic landscape of medical device safety, timely and defensible decisions about field actions hinge on a company’s ability to interpret post-market signals through a risk-based lens. The Health Hazard Evaluation (HHE) process serves as the critical bridge, linking these signals to patient safety and regulatory response. Yet, organizations often struggle to ensure consistency, objectivity, and alignment with ISO 14971 principles when conducting HHEs under real-world constraints.

This presentation will explore practical strategies for integrating ISO 14971 risk management principles into a structured, cross-functional HHE process to support sound, documented decision-making. When a data-driven and defensible risk-based approach is systematically employed to translate post-market data into clear identification of hazardous situations and harms, risk estimation and acceptability criteria can then guide whether issues warrant escalation to field action.  Each HHE serves as a formal record demonstrating that the organization systematically assessed a potential health risk and made an informed and justified decision, linking post-market data, hazard analysis, and medical assessment directly to the final action.

This presentation will not only focus on the application of risk management principles in complete and systematic HHE documentation and how ISO 14971 elements apply to the HHE process, but will also highlight the importance of feedback loops—ensuring that insights from HHEs inform ongoing risk management activities. By applying a consistent, data-driven, and clinically informed approach, manufacturers can strengthen compliance, improve transparency, and most importantly, protect patient safety.