Quality Assurance
InfiMed is committed to providing quality products and services to its customers worldwide.
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: 2000 and ISO 13485:2003 standards by Intertek Testing Services NA, Inc.
- The last FDA audit was conducted in May 2004 utilizing a baseline Level 2 Quality System Inspection Technique (QSIT). No Inspectional Observations were issued (FDA-483).
- Our Registrar conducts ISO/CMDCAS audits annually.
- 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
InfiMed openly welcomes comments from our customers regarding the quality of our products and services. Many of which have been improved based on your ideas.
InfiMed's Quality Policy
It is InfiMed's philosophy that through consistency in quality improvements, InfiMed will provide safe and effective products that meet or exceed our customers' expectations.
