The International Organization for Standardization (ISO) recently enhanced its language on the voluntary standard advising medical device makers on best practices for risk management. The move addresses best practices for weighing the benefits against the flaws of medical devices when determining whether they should remain available on the market. Medtech Insight interviewed an architect of the revised language for ISO 14971 for an inside look on what impact of the ISO’s new benefit-risk language may have on the way device manufacturers devise their risk management plans.