Quality and risk management play a crucial role in the medical device industry, ensuring both patient safety and business success. High-quality medical devices not only safeguard patients but also enhance a company’s reputation, minimize liability risks, and ensure compliance with regulatory standards. At the same time, risk management, including safety and security risk management, is essential to mitigate potential hazards associated with medical devices. Medical devices are subject to rigorous oversight due to their direct impact on human health. Any failure in quality or risk management can lead to severe consequences, including patient harm, legal liabilities, and financial losses. The increasing complexity of medical technologies, combined with globalization and digital transformation, has further heightened the need for robust quality and risk management systems. This chapter provides an overview of the importance of quality and risk management, their regulatory frameworks, and how they contribute to business success. The integration of these disciplines is crucial in maintaining compliance, ensuring product reliability, and fostering trust among healthcare providers and patients.