Sterile Medical Device Packaging and Labeling

The contract involves the provision of sterile barrier packaging, labeling, and barcoding services for a Class III spinal implant device, ensuring full compliance with FDA and federal medical device regulations. This subcontract is categorized under NAICS code 325991, reflecting its focus on other medical and dental equipment manufacturing, and is managed by the Department of Veterans Affairs through the Network Contract Office 23. The services must meet stringent quality and sterility standards required for implantable medical devices, with packaging and labeling designed to maintain product integrity and enable traceability throughout the supply chain. All activities must align with current Good Manufacturing Practices and federal requirements governing Class III devices, which are subject to the highest level of regulatory control due to their critical role in sustaining or supporting human life. The work is to be performed in accordance with federal standards, though the specific place of performance is not detailed in the provided information. The contract was posted on May 7, 2026, and is listed under a subcontract type, indicating it is part of a larger procurement arrangement. While no set-aside designation or point of contact is specified, the involvement of the Department of Veterans Affairs underscores the importance of reliable, compliant packaging for devices used in veteran healthcare settings. Successful performance requires rigorous adherence to packaging validation, labeling accuracy, and barcoding protocols to ensure regulatory compliance and patient safety.