Medical Device Packaging and Labeling

The contract entails the design and execution of sterile barrier packaging, pouch sealing, labeling, and full UDI compliance for a TAVR medical device, ensuring adherence to stringent regulatory and manufacturing standards. The work involves creating and validating packaging systems that maintain sterility throughout distribution and use, integrating precise labeling protocols and Unique Device Identification requirements to meet FDA and international regulatory expectations. This subcontract is positioned under the NAICS code 326199, indicating it falls under other plastic product manufacturing, and is managed by the Department of Veterans Affairs through the Network Contract Office 23. The contract was posted on May 15, 2026, with no specified place of performance or point of contact provided, leaving execution logistics to be determined by the selected subcontractor. The scope prioritizes quality, traceability, and compliance over geographic delivery requirements.