The quality system was further designed to meet U.S. FDA Good Manufacturing Practices (cGMP) requirements. AccuVein has begun shipping the device in the U.S. and recently announced agreements with two large group purchasing organizations. In addition the device is available on the General Services Administration Schedule, bringing AccuVein to blood centers, hospitals, and government-affiliated institutions across the nation.
“AccuVein launched the breakthrough vein illumination device to help healthcare professionals locate hard-to-find veins and is committed to ensuring its products are of the highest quality while meeting healthcare provider and patient needs,” said Stephen P. Conlon, President of AccuVein. “Receipt of this approval from BSI, an objective and accredited organization, is a critical step forward in our path to deliver vein illumination with AccuVein to healthcare practitioners around the globe.”
To achieve this three–year certification, AccuVein had to demonstrate that their quality system conforms to the exacting customer and regulatory standards of the ISO. ISO 13485:2003 is specifically designed for regulatory compliance of medical device companies. It supplements ISO 9001 with additional requirements including process control, design control, retention of records, accountability, traceability, and customer satisfaction.
AccuVein achieved this key milestone following a careful assessment of their quality management system by BSI Group, a global provider of management systems assessment, certification and training services, with more than 60,000 certified locations and clients in over 100 countries. AccuVein’s quality system meets ISO standard and U.S. FDA Good Manufacturing Practices requirements.
For a copy of AccuVein’s ISO 13485:2003 certificate, please visit https://www.accuvein.com/regulatory/
For more information on AccuVein, please visit accuvein.com.
BSI Group is a global provider of management systems assessment, certification and training services, with more than 60,000 certified locations and clients in over 100 countries.
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