In medical device authorization, the pivotal question remains: Do the benefits outweigh the risks? Despite being foundational to the ISO 14971 safety risk management framework, benefit–risk assessment continues to challenge the MedTech industry. Quantitative, engineering-based methods offer structure and consistency, yet they often fall short of addressing the uncertainty, variability, and context-dependence inherent in clinical use.

This presentation introduces a qualitative, argument-based approach designed to complement traditional risk assessment methods. By emphasizing critical thinking, evidence articulation, and technical writing, engineers can more effectively construct transparent, defensible benefit–risk arguments. This approach reframes the assessment process from a purely analytical task into a reasoned, evidence-driven narrative that integrates both technical and clinical perspectives.

Embedding this mindset into safety risk management can improve decision quality, enhance regulatory confidence, and accelerate safe innovation. The presentation will discuss how employing a qualitative structured argument strengthens the clarity and credibility of benefit–risk evaluations, ultimately contributing to more rigorous medical device safety decision-making.