Medical Device Packaging, Labeling & Serialization

The contract pertains to the packaging and labeling of a Transcatheter Aortic Valve Replacement (TAVR) system in full compliance with FDA regulations, Unique Device Identification (UDI) standards, GS1 protocols, and sterile packaging requirements. It mandates complete serialization and UID compliance to ensure traceability and regulatory adherence throughout the distribution and use of the medical device. All labeling and packaging activities must meet stringent international and domestic standards to guarantee safety, accuracy, and audit readiness. The subcontract is issued under NAICS code 339113 and is managed by the Department of Veterans Affairs through the Network Contract Office 23. The work is expected to be performed in accordance with federal medical device compliance frameworks, with no specific geographic performance location detailed. The solicitation was posted in April 2026 and does not indicate a set-aside classification, suggesting it is open to any qualified subcontractor capable of delivering compliant packaging and labeling services for high-risk Class III medical devices.