Medical Device Sterile Packaging and Labeling

The contract pertains to the design, validation, and production of sterile packaging and compliant labeling for a heart implant device, ensuring full adherence to regulatory standards. This includes the implementation of Unique Device Identification (UDI), accurate lot and serial numbering, and clearly marked expiration dates to meet federal medical device tracking and safety requirements. All packaging must maintain sterility throughout storage and transport while aligning with current industry and FDA guidelines for implantable medical devices. The work is being procured as a subcontract under the Department of Veterans Affairs through the 261-NETWORK Contract Office 21, with the NAICS code 326191 indicating classification under other plastic product manufacturing. The solicitation was posted on April 29, 2026, and performance is expected to occur under the authority of the VA’s contracting structure, though specific location details for performance are not provided. The emphasis is on precision, traceability, and regulatory compliance to support patient safety and device accountability in clinical use.