After our most recent audit this week, FDI will be re-certified as ISO 13485:2016 compliant. As a participant in the Medical Device Single Audit Plan (MDSAP) program for ISO 13485, this rigorous inspection certifies that our medical devices meet the requirements of ISO 13485, the U.S. Food and Drug Administration, and Health Canada.
Recertification continues to allow us to strive to design and produce the safest, most reliable, and most effective devices on the market.