This is part 2 of a 2-part series. For part 1, see: Building Robust IVDs – Fundamentals of regulated product development (Part 1) Risk management: a regulatory cornerstone Risk management is not optional—it is a core requirement of medical device and IVD regulations worldwide. It is defined as the systematic process of identifying, analysing, evaluating, controlling, and monitoring risks associated with a device throughout its lifecycle. Effective risk management protects: Pa