EN ISO 13485

EN ISO 13485 is an international standard that sets out the requirements for a quality management system specifically for designing, manufacturing, and servicing medical devices. It ensures that companies consistently produce safe, effective, and reliable medical products. By adhering to this standard, organizations demonstrate their commitment to high-quality processes, risk management, and regulatory compliance, helping protect patient safety and improve product performance. Essentially, it provides a structured framework for medical device companies to manage quality throughout their operations.