The FDI Quality Management System includes the design and manufacture of sterilizers and supportive accessories for the medical device industry. As the manufacturer, FDI is the sole driver of all steps in the product life cycle.

FDI currently hold the following domestic and international certifications:

ISO 13485:2016 Medical Device Quality System

FDA 21 CFR 801, 803, 806, 820

ASME Boiler and Pressure Vessel Code, Section VIII, Division 1, 2017

The National Board of Boiler and Pressure Vessel Inspectors (“NB” and “R” Stamp)


UL 61010-1 2nd Edition

IEC 61010-2-040 1st Edition including Part 2-040

ISPM 15: 2009 Regulation of Wood Packaging Material in International Trade