Which organization sets international standards for the medical device industry?

The International Organization for Standardization (ISO) is recognized for setting international standards across various industries, including the medical device sector. ISO develops and publishes standards that ensure the safety, quality, and efficiency of medical devices worldwide. These standards facilitate international trade and help organizations comply with regulatory requirements by establishing a common framework for safety and performance.

The ISO's standards for medical devices, such as ISO 13485 for quality management systems, are essential for manufacturers globally, as they demonstrate a commitment to delivering safe and effective products. Compliance with ISO standards often aids manufacturers in gaining regulatory approval in multiple regions, reflecting the organization's pivotal role in the healthcare industry.

Other organizations listed have specific functions but do not primarily focus on setting international standards for medical devices. For instance, ANSI concentrates on voluntary consensus standards in the U.S., the FDA is responsible for regulating medical devices within the United States, and the WHO focuses on global public health and may provide guidelines but does not set binding standards for medical devices. Hence, the prominence of ISO in the establishment of international standards makes it the correct choice.