As global regulatory pressures tighten and product designs increase in complexity, medical device manufacturers are increasingly considering changes to sterilization modalities. This presentation will provide a comprehensive overview of the critical considerations and step-by-step processes involved in changing sterilization modalities for medical devices. Topics will include feasibility assessment, risk-based decision making, material compatibility studies, the planning and execution of validation testing, and maintaining regulatory compliance. Additionally, the presenters will explore the regulatory landscape, with guidance on engaging with global regulatory bodies, compiling robust technical documentation, and navigating submission requirements.