The term "risk" originates from the Italian word "risicare," meaning "to dare." In the context of medical devices, various stakeholders, including designers, manufacturers, patients, and surgeons, contribute to different types of risks. Several standards and guidelines address medical device safety, such as ISO 14971, IEC 60601-1, IEC 62304, IEC 62366, and ISO 10993-1. Among these, ISO 14971 stands out as the central standard for medical device risk management, recognized in both the European Union and the United States. Consequently, implementing risk management processes in line with ISO 14971 is a legal requirement in many countries, essential for obtaining approval to market medical devices. The present study focuses on the ISO 14971 standard, aiming to familiarize future researchers with its fundamental terminology and guide them in effectively preparing risk management plans and reports specific to medical devices.