Products- ISO 13485 Certified Facility

ISO 13485 is an International Organization Standardization that acknowledges comprehensive quality management systems for the design and manufacture of medical devices with certified facilities. By meeting this strenuous facility standard, FXI adheres to higher standards in creating superior quality products. ISO 13485 has become the standard to measure quality in the medical industry. Recognized by the Global Harmonization Task Force (GHTF), ISO 13485 is now the model QMS standard. By acquiring this standard for our facility, FXI offers increased efficiency, cost savings, and more effective risk management in creating our products for the medical industry.

• Overlays
• Positioners
• Stretchers
• Wheelchairs