13485 (ISO 13485)

ISO 13485 is an international standard that sets requirements for quality management systems specifically for organizations involved in designing, manufacturing, and providing medical devices. It ensures these companies consistently produce safe, effective, and reliable medical products by establishing processes for quality control, risk management, and regulatory compliance. Essentially, it acts as a blueprint for companies to maintain high standards, reduce errors, and meet legal and customer expectations, ultimately ensuring patient safety and product effectiveness in healthcare.