Sterile Medical Device Packaging and Labeling Services

The contract involves providing comprehensive packaging, sterilization validation, and labeling services for stent grafts, ensuring full compliance with FDA regulations, Department of Veterans Affairs requirements, and international standards including ISO 11607 for sterile medical device packaging and 21 CFR Part 820 for quality system regulations. All labeling must adhere to GS1-128 barcoding standards to guarantee traceability and accurate identification throughout the supply chain. The work is performed under a subcontract arrangement managed by the Department of Veterans Affairs through its 250-NETWORK Contract Office 10, with the North American Industry Classification System code 811211 indicating the focus on medical and dental equipment and supplies repair and maintenance services. The packaging and validation processes must consistently meet rigorous sterility assurance levels and documentation requirements to support device safety, efficacy, and regulatory approval for use in VA healthcare facilities.