AccuVein Inc., the global leader in vein visualization, today announced that it has received ISO 13485:2016 certification, the latest version of the internationally recognized quality standard for medical devices. AccuVein first earned ISO 13485 certification in 2009.
The ISO 13485:2016 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 vein access and avoidance, have been shown to improve first stick success rate by 3.5 times, reduce patient pain by 39% and reduce procedure time by 78%.
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 consistency and high quality in AccuVein products and services, allowing those who have adopted or plan to adopt AccuVein vein visualization to be confident in AccuVein products. The fact that vein visualization is the standard of care, and that 8 out of 10 facilities who adopt vein visualization choose AccuVein, is evidence of this confidence in the marketplace.
“AccuVein strives toward excellence in the medical device industry through our customer, employee and operational commitments and a worldwide medical professional population that relies on that excellence. Our commitment toward continuous improvement to meet and exceed current and future customer expectations is exhibited by our achieving ISO 13485:2016 certification,” said Robert Wick, Director of Quality and Regulatory.
The ISO (International Organization for Standardization) is the world’s largest developer and publisher of International Standards. AccuVein’s ISO 13485:2016 certificate was awarded by the British Standards Institution (BSI).
About AccuVein Inc.
AccuVein Inc. is the global leader in vein visualization technology. AccuVein’s flagship product, the AV400, is the world’s only hand-held, non-contact vein illumination solution. It allows healthcare professionals to see a map of peripheral veins on the skin’s surface with the goal of accessing or avoiding veins. It is built on proprietary technology as embodied in its growing patent portfolio that covers a broad range of imaging and medical diagnostic technologies. AccuVein is known as a medical device leader and innovator, having won numerous awards including the SPIE (International Society of Photonics Engineers) Prism award for most innovative medical device. AccuVein is in use at more than 5,000 facilities and available for sale in over 130 countries worldwide. To see a demonstration of AccuVein in action, please visit www.accuvein.com.