InfiMed annually conducts internal audits on all elements of our Quality System to ensure compliance with FDA, ISO, and CMDCAS requirements.
All products designed and manufactured by InfiMed are subject to the jurisdiction of the U.S. Food and Drug Administration (FDA) and regulated under the Food, Drug, and Cosmetic Act. InfiMed’s quality system is registered to ISO 9001:2008 and ISO 13485:2003 standards by Intertek Testing Services NA, Inc.
InfiMed annually conducts internal audits on all elements of our Quality System to ensure compliance with FDA, ISO, and CMDCAS requirements.
InfiMed strives for continuous improvement in its products and services by incorporating elements of Six Sigma, TQM, and other quality tools into our quality system. All product lines are evaluated with respect to both product safety and electromagnetic compatibility (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 Intertek Testing Services NA, Inc. (Intertek-ETL-SEMKO). Our products have been tested and approved to all applicable UL, CSA, and IEC standards, including:
UL 60601-1
CAN/CSA C22.2 No. 601.1
IEC 60601-1
IEC 60601-1-1
IEC 60601-1-2
IEC 60601-1-4
