AccuVein Inc., the global leader in vein visualization, today announced that it has again received ISO 13485:2003 certification, an internationally recognized quality standard for medical devices. AccuVein first earned ISO 13485 certification in 2009.
The ISO 13485:2003 certification covers the design, development, production, sales and service of AccuVein vein visualization devices. The devices, which project a map of peripheral veins on the skin’s surface to help clinicians with venous access, have been shown to significantly improve first stick success rate and reduce pain.
This certification demonstrates that AccuVein has successfully implemented a quality management system that conforms to the worldwide standard for medical device and diagnostic manufacturing. ISO certification helps ensure consistent, high quality in the products and services provided to AccuVein customers allowing them to be confident in AccuVein products. The fact that AccuVein vein visualization is the standard of care, with 8 out of 10 facilities choosing AccuVein, is evidence of this customer confidence.
“At AccuVein, we are committed to developing the highest quality products in compliance with ISO standards and respective regulatory authorities internationally. We believe that receiving ISO 13485 recertification is recognition of the quality processes we have adopted and is a direct reflection of our commitment to operational and production excellence,” says Joe Zott, Vice President of Engineering and Operations.
The ISO (International Organization for Standardization) is the world’s largest developer and publisher of International Standards. AccuVein’s ISO 13485:2003 certificate was awarded by the British Standards Institution (BSI).