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Certifications

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)
ANSI/AAMI ST8: 2013
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