ISO 13485:2003 Certification is recognized as a worldwide quality certification specific to the Medical Device industry. According the International Organization for Standardization, “ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements applicable to medical devices and related services”.
The ISO certification as well as a successfully reviewed Technical File is required for a company to sell any medical device.
