ISO 13485 (Medical Devices Quality Management)

ISO 13485 is an international standard that sets the requirements for a quality management system specifically for medical device manufacturing and related services. It ensures that companies consistently produce safe, effective, and reliable medical devices by following strict processes for design, production, and delivery. This standard helps organizations demonstrate their commitment to quality, regulatory compliance, and continuous improvement, ultimately protecting patients and healthcare professionals. It’s used worldwide to ensure that medical devices meet high standards for safety and performance throughout their lifecycle.