ISO 13485 is an international standard that outlines the requirements for a Quality Management System (QMS) specifically tailored for the design, development, production, and servicing of medical devices. Its primary focus is on regulatory compliance, risk management, and ensuring that products meet both customer expectations and regulatory standards throughout their lifecycle. The certification applies to all organizations involved in the medical device supply chain, from manufacturers to distributors. By achieving ISO 13485, companies demonstrate their commitment to delivering high-quality medical devices that meet global standards.