The International Organization for Standardization has developed more than 17,000 international standards on numerous subjects. For medical device companies, the most important of these standards is ISO 13485, which provides internationally recognized guidelines pertaining to quality management systems (QMS). Certification to ISO 13485 doesn’t necessarily fulfill the requirements of regulatory agencies such as the U.S. Food and Drug Administration (FDA), but it will bring a company’s QMS in line with the FDA’s quality system regulation (QSR) standards.