ISO 13485:2016 is an international standard that specifies requirements for a quality management system (QMS) specifically tailored to the medical devices industry. This standard outlines the criteria for organizations involved in the design, development, production, installation, and servicing of medical devices to establish and maintain a quality management system that ensures compliance with regulatory requirements and meets customer expectations. ISO 13485:2016 places a strong emphasis on risk management, process control, and traceability within the medical device manufacturing and service environments. By implementing ISO 13485:2016, organizations can demonstrate their commitment to producing safe and effective medical devices while maintaining the highest levels of quality and regulatory compliance. This standard is essential for medical device manufacturers, suppliers, and service providers looking to enhance product quality, improve customer satisfaction, and achieve regulatory approval in global markets.