ISO 13485 Certification in Iran is vital for medical device manufacturers seeking to meet international standards for quality management systems. This certification ensures that companies comply with regulatory requirements for the design, production, and distribution of medical devices, promoting product safety and effectiveness. By obtaining ISO 13485 certification, Iranian manufacturers can enhance their credibility, improve operational efficiency, and access global markets. It also fosters continual improvement, risk management, and regulatory compliance, making it an essential standard for companies aiming to build trust and maintain high-quality standards in Iran’s growing medical device industry.