ANSI/AAMI/ISO 13485

ANSI/AAMI/ISO 13485 is an international standard that sets requirements for quality management systems in the design, manufacture, and distribution of medical devices. It ensures that companies consistently produce safe, effective, and reliable medical products. The standard emphasizes risk management, regulatory compliance, and process improvement, helping organizations meet legal and customer expectations. By following these guidelines, manufacturers can enhance product quality, reduce errors, and ensure patient safety throughout the product lifecycle.