Use of Standards in Medical Device Global Regulatory Strategy

Standards are documents providing requirements, specifications, guidelines and characteristics that can be used to ensure materials, products, processes and services consistently are fit for their purpose. Multiple standards developing organizations (SDOs) develop and maintain standards, and many of them related to medical devices and/or components and materials used in the medical devices. Additionally regulatory bodies have started recognizing standards for regulatory purposes around the globe and this trend is expected to continue. This session is intended to discuss high level overview of standards, its development process, why they matter to you, and how to get involved in the development process.