FDI enters the world’s leading medical device manufacturers’ elite company by gaining certification with the ISO 13485:2016 medical device standard. ISO 13485 is an International Organization for Standardization (ISO) standard published for the first time in 1996; it represents the requirements for a comprehensive quality management system to design and manufacture medical devices. This standard supersedes earlier documents such as EN 46001 and EN 46002 (both 1997), the previously published ISO 13485 (1996 and 2003), and ISO 13488 (also 1996).
