InfiMed is committed to providing quality products and services to its customers worldwide.

InfiMed's quality system is ISO 9001 (2001) and ISO 13485 compliant, and all of the products that InfiMed designs are compliant with the appropriate standards.

• The first audit occurred in 1995, and InfiMed was found to be in compliance. Since that time, periodic surveillance audits are conducted to confirm continuing compliance.
• InfiMed conducts internal audits to ensure compliance and to find any additional improvements that can be incorporated into the quality system.
• InfiMed strives to go beyond FDA quality requirements by incorporating elements of Six Sigma, TQM, and other quality philosophies into our quality system.

All product lines are evaluated with respect to both product safety and electromagnetic compliance (EMC) regulations to allow sale in the United States, Canada, Europe, and Asia. Each product is listed and approved by an independent third party testing lab that is recognized in the United States and Canada and is a certified/notified body for Europe.

Our products have been ETL, CSA and CE registered and evaluated to the following standards by our registrar Intertek Testing Services:

• FDA 510(K)
• CE Mark to MDD
• UL 2601-1
• CAN/CSA C22.2 No. 601.1
• IEC 60601-1
• IEC 60601-1-1
• IEC 60601-1-2
• IEC 60601-1-4

InfiMed openly welcomes input from our customers. Many of our products and services have been improved based on your ideas. If you have feedback or quality concerns, please contact us anytime: quality@infimed.com

InfiMed Quality Policy
InfiMed instills the philosophy that we shall use continuous improvement to strive to meet or exceed our customer's expectations.