ISO 13485 is an international standard that outlines the requirements for a quality management system specifically for organizations involved in the design, production, and distribution of medical devices. It ensures that these organizations consistently meet regulatory requirements and customer expectations, promoting safety and effectiveness in medical products. The standard emphasizes a process-oriented approach, focusing on risk management and continuous improvement. By adhering to ISO 13485, companies can enhance their operational efficiency and demonstrate their commitment to quality, which is crucial for gaining trust from customers and regulatory bodies in the medical device industry.