Certifications

FDI currently holds the following domestic and international certifications:

FDA 21 CFR 820, 801, 803, 807, and 807

ISO 13485:2016 Medical Device Quality System

ANSI/AAMI ST8, ST55

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

ASME Boiler and Pressure Vessel Code Section VIII, Division 1

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

State of Tennessee Occupational Safety and Health Administration