AccuVein LLC'S quality system has received an International Organization for Standardization (ISO) 13485 Certification. This certifies to customers around the globe AccuVein's commitment to the quality and safety of its medical device design, development, production, installation and delivery procedures.
The quality system was further designed to meet US FDA Good Manufacturing Practices (cGMP) requirements. AccuVein has begun shipping the AV300 in the US and announced agreements with two large group purchasing organizations. In addition the AV300 is available on the General Services Administration Schedule, bringing the AccuVein AV300 to blood centers, hospitals, and government-affiliated institutions across the nation.
AccuVein launched the AV300 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 the AV300 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. AccuVein’s quality system meets ISO standard and US FDA Good Manufacturing Practices requirements.